Chhattarpur, India

A Study of Brentuximab Vedotin With Doxorubicin, Vinblastine and Dacarbazine in Adults With Hodgkin Lymphoma in India

A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Ulcerative Colitis on Advanced Therapies

This study is a multicenter, randomized, factorial-design, double-blind, controlled trial investigating the effects of fecal microbiota transplantation (FMT) and dietary interventions in patients with mild to moderate, treatment-naïve, active inflammatory bowel disease. The trial is being conducted across multiple clinical centers, with a central microbiome analysis facility. Randomization and Blinding: Randomization: Centralized, computerized randomization is employed to ensure balanced treatment allocation. The permuted block method, along with stratification based on disease characteristics, ensures equal distribution across intervention arms Blinding: Patients, investigators collecting clinical data, and endoscopic video assessors are blinded to treatment allocation. The dietitian and endoscopist performing FMT (or sham FMT) are unblinded Intervention Arms: Participants are assigned to one of four treatment arms: FMT + Anti-inflammatory Diet (AID) +Advanced therapy FMT + Sham Diet+ Advanced therapy Sham FMT + AID+ Advanced therapy Sham FMT + Sham Diet+ Advanced therapy FMT is administered via colonoscopy at 0, 2, and 6 weeks, with responders receiving maintenance doses every 8 weeks until week 48 Participant Timeline and Assessments: Baseline Assessments: Clinical, laboratory, and endoscopic evaluations, including serological tests, inflammatory markers, and microbiome profiling. Follow-up Schedule: Visits occur at Week 0, Week 6, Week 10, and then every 8 weeks until Week 48. Endoscopic Monitoring: Colonoscopy is performed at baseline, Week 10, and Week 48. Centralized endoscopic video scoring ensures consistency Data Collection and Management: Paper CRF's and Electronic Data: The paper based CRF's will be filled first and then data will be entered into a REDCap software. Dietary Monitoring: Participants will use the IBD NutriCare mobile application for diet tracking. Microbiome Analysis: Fecal samples are processed and analyzed at a designated microbiome research center. Safety Monitoring and Compliance: Adverse Event Reporting: All safety events, including potential serious adverse events (SAEs), are logged and monitored by the Data and Safety Monitoring Board (DSMB). Protocol Deviations: Documented and assessed for impact on trial integrity. Training and Quality Control: Regular site training ensures adherence to the protocol, and periodic audits maintain data quality

A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Crohn Disease

This study is a multi-center, double-blind, factorial randomized controlled trial designed to evaluate the efficacy of microbiome manipulation strategies using fecal microbiota transplantation (FMT), Crohn's Disease Exclusion Diet (CDED), or their combination in treatment-naïve patients with mild to moderate active Crohn's Disease (CD). Study Setting The trial is conducted at six FMT centers across India, with one additional center dedicated to microbiome analysis: AIIMS, New Delhi, India Dayanand Medical College, Ludhiana, India PGIMER, Chandigarh, India Lisie Hospital, Kochi, India IMS, BHU, Varanasi, India Sion Hospital, Mumbai, India IIIT-Delhi, India(for microbiome analysis) Intervention Details: Fecal Microbiota Transplantation (FMT)- Patients receive a 3-day course of oral vancomycin (500 mg BD) before the first FMT. Freshly prepared 50 g stool is used for each FMT, and the transplant is administered within 4 hours of preparation. FMT is delivered via colonoscopy at weeks 0, 2, and 6, followed by 8-weekly maintenance sessions for responders at weeks 10, 18, 26, 34, 42. Multiple donors (n≥2) are used to ensure microbiome diversity. The first FMT session is instilled in the right colon/terminal ileum post bowel preparation, whereas maintenance sessions involve left-colon infusion without bowel preparation. Crohn's Disease Exclusion Diet (CDED)- Patients assigned to CDED follow a phased dietary protocol designed to limit exposure to pro-inflammatory dietary components and enhance gut microbiome stability. CDED consists of an induction and maintenance phase, with structured dietary charts and counseling provided by a dietitian. Compliance is monitored via telephonic interviews and a dedicated diet tracking app (IBD NutriCare). Sham Interventions- Sham FMT: Patients receive sterile water or saline infusions via colonoscopy at the same time points as FMT. Sham Diet: Patients receive general dietary advice but do not follow the CDED protocol. Randomization and Blinding- Central randomization is conducted using a secure web-based system (REDCap), utilizing stratified randomization based on disease extent. The study follows a double-blind approach: Blinded: Patients, clinical assessors, and endoscopic scorers. Unblinded: Endoscopists administering FMT/sham FMT and dietitians providing dietary counseling. Oral vancomycin and placebo capsules are identically packed to maintain blinding. Data Collection and Assessments- Baseline Assessments (Week 0) Clinical Assessment: Crohn's Disease Activity Index (CDAI), symptom scoring, and dietary adherence evaluation. Laboratory Tests: Hemogram, renal/liver function, CRP, ESR, fecal calprotectin, and microbiome profiling. Endoscopy: SES-CD scoring with high-definition endoscopic video recording. Histology: Biopsy samples are analyzed using Distribution Chronicity and Activity (DCA) scoring. Follow-up Assessments- Clinical assessments at weeks 0, 2, 4, 6, 10, and every 8 weeks thereafter. Endoscopic assessments at baseline, week 10, and week 48, with central reading of all videos. Fecal microbiome analysis at baseline, week 10, and week 48. Safety and Monitoring- Adverse Events (AEs) graded per CTCAE criteria (Grades 1-5). Serious Adverse Events (SAEs) include hospitalization, life-threatening conditions, or death. DSMB reviews interim safety data at week 10 and 24. Emergency unblinding is permitted for critical medical decisions. Data Management- Data is collected using REDCap, with role-based access controls. Endoscopic images and videos are securely stored for centralized analysis. Microbiome sequencing data is processed at IIIT-Delhi. Statistical Considerations- Sample size calculation: 168 patients (42 per arm, 90% power). Analysis Plan: Intention-to-treat (ITT) and per-protocol (PP) analyses. Longitudinal mixed-effects modeling for microbiome shift

A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Crohn Disease on Advanced Therapies

This is a multicenter, double-blind, factorial randomized controlled trial (RCT) evaluating the efficacy of microbiome manipulation strategies in patients with active Crohn's Disease (CD) undergoing advanced therapy (biologics or small molecules). The study will be conducted across six clinical centers in India, with an additional center designated for microbiome analysis. Randomization and Blinding: Randomization: Centralized, computer-generated randomization using permuted blocks of 8, 12, and 16 to ensure equal distribution across intervention arms. Stratification: Not more than 1/3rd patients should be biological therapy exposed Blinding: The blinded team includes patients and principal investigators. Endoscopists administering FMT/sham FMT and dietitians providing dietary counseling will be unblinded Sham-Control Methods: FMT Sham: Sterile clean water infusions via colonoscopy. Diet Sham: Dietary counseling without any modification Intervention Arms: Patients are randomized into one of four treatment groups: FMT + CDED + Advanced Therapy (Group A) FMT + Sham Diet + Advanced Therapy (Group B) Sham FMT + CDED + Advanced Therapy (Group C) Sham FMT + Sham Diet + Advanced Therapy (Group D) Fecal Microbiota Transplantation (FMT): FMT Route: Administered via colonoscopy. FMT Schedule: Induction Phase: Weeks 0, 2, and 6. Maintenance Phase: Every 8 weeks (weeks 10, 18, 26, 34, 42) for responders. Preparation: Donor Selection: Multi-donor approach with prescreening FMT Processing: 50 g stool freshly prepared and instilled within 4 hours. Delivery Locations: Week 0 (Bowel Preparation): Right colon/terminal ileum. Weeks 2 and 6 (No Bowel Preparation): Left colon. Crohn's Disease Exclusion Diet (CDED) Diet Structure: Induction Phase (Weeks 0-6): Elimination of specific pro-inflammatory dietary components. Maintenance Phase (Weeks 6-48): Gradual reintroduction of certain food groups. Monitoring: Adherence tracked using the IBD NutriCare app, diet recall logs, and DietCal software. Sham Diet: Patients follow a standard healthy diet with general dietary counseling. Assessments and Data Collection Baseline Assessments (Week 0) Clinical Data: Crohn's Disease Activity Index (CDAI), stool frequency, rectal bleeding, and symptom tracking. Laboratory Tests: Hemogram, renal/liver function tests, blood glucose. Inflammatory Markers: C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), fecal calprotectin (FCP). Microbiome Analysis: Stool samples stored at -80°C for sequencing. Endoscopic Evaluation: Scoring: Simple Endoscopic Score for CD (SES-CD). Blinded Central Review: Videos assessed by two independent readers; discrepancies adjudicated by a third reader. Histology: Biopsies analyzed using DCA score (Distribution Chronicity and Activity). Follow-up Assessments Visit Schedule: Induction Phase: Weeks 2, 4, 6, and 10. Maintenance Phase: Every 8 weeks (weeks 18, 26, 34, 42, and 48). Clinical Assessments: CDAI, PRO2 symptom tracking, medication adherence checks. Endoscopy: Week 10 and Week 48; central scoring of videos. Diet Adherence: Assessed at weeks 2, 4, 6, and 10, then every 8 weeks. Microbiome Sampling: Stool samples collected at weeks 10 and 48. Safety Monitoring and Adverse Events Adverse Event (AE) Classification: CTCAE Grading (Grade 1-5) for treatment-related AEs. Serious Adverse Events (SAEs): Hospitalization, life-threatening events, or disability. Safety Monitoring Plan: Pre-procedural safety checks for each FMT session. Immediate post-FMT monitoring (48 hours). Late safety assessments (14 days post-FMT, then every visit). Unblinding Procedure: Allowed only for SAE management with DSMB approval. Data Management and Statistical Analysis Electronic Data Capture (EDC): Platform: REDCap database with tiered access permissions. Audit Trails: Secure logs of data entry and modification. Dietary Data Processing: IBD NutriCare app logs converted into macronutrient composition reports. Adherence scoring based on 80% compliance threshold. Microbiome Data Processing: Samples sequenced at IIIT-Delhi, analyzed for diversity indices and metabolic pathways. Statistical Plan: Primary Analysis: Intention-to-treat (ITT) and per-protocol (PP) analyses. Longitudinal Modeling: Mixed-effects models for repeated measures. Effect Size Estimation: Sample size: 168 patients (42 per arm).

A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Ulcerative Colitis

This study is a multi-center, double-blind, 2 × 2 factorial, randomized sham-controlled trial designed to evaluate the effects of fecal microbiota transplantation (FMT) and dietary modification in treatment-naïve patients with mild to moderate active ulcerative colitis (UC). The trial consists of four treatment arms: FMT + Anti-inflammatory Diet (AID) + 5-ASA (Group A) FMT + Sham Diet + 5-ASA (Group B) Sham Transplantation + AID + 5-ASA (Group C) Sham Transplantation + Sham Diet + 5-ASA (Group D) All groups receive 5-aminosalicylic acid (5-ASA) as the standard medical therapy. Study Setting The trial is conducted at six FMT centers across India, with one additional center dedicated to microbiome analysis: AIIMS, New Delhi, India Dayanand Medical College, Ludhiana, India PGIMER, Chandigarh, India Lisie Hospital, Kochi, India IMS, BHU, Varanasi, India Lokmanya Tilak Municipal Medical College, Mumbai, India IIIT-Delhi, India (for microbiome analysis) Intervention Details Fecal Microbiota Transplantation (FMT) Patients receive three FMT sessions (weeks 0, 2, 6) during induction and additional 8-weekly maintenance sessions (weeks 10, 18, 26, 34, 42) for responders. FMT is delivered via colonoscopy; at week 0, it is instilled into the right colon/terminal ileum (post bowel preparation), while for maintenance sessions, it is instilled in the left colon without bowel preparation. Each FMT dose is 50 g stool, freshly prepared within 4 hours of collection. Multiple donors are used to ensure microbiome diversity Anti-Inflammatory Diet (AID) Patients assigned to AID receive a nutritionally tailored diet that promotes T-regulatory cell expansion, microbiome stability, and gut barrier integrity. The diet excludes gluten-based grains, dairy products, and pro-inflammatory foods while including fermented foods, cruciferous vegetables, and polyphenols. Patients are provided diet charts, receive dietary counseling, and are monitored via diet app named IBDNutricare. Sham Interventions Sham FMT: Instead of donor stool, patients receive sterile water infusions via colonoscopy at the same time points as FMT. Sham Diet: Patients receive dietary counselling without specific modifications Randomization and Blinding Central randomization is conducted via REDCap. Block randomization will be done in which blocks of 8 will be created for the randomization. Further, stratified randomization will also be done in which <25% Proctitis involving Ulcerative Colitis patients. Blinding: Patients, investigators collecting clinical data, and those assessing endoscopic images are blinded. The endoscopist administering FMT and the dietitian providing dietary counseling are unblinded Data Collection and Assessments Baseline Assessments (Week 0) Clinical Evaluation: Patient-reported outcomes (PRO-2), stool frequency, rectal bleeding assessments. Laboratory Tests: Hemogram, renal/liver function, CRP, ESR, fecal calprotectin, and microbiome profiling. Endoscopy: Mayo Endoscopic Score (MES) assessment with high-definition recordings. Histology: Biopsy samples assessed using Robarts Histologic Index (RHI) and Distribution Chronicity and Activity (DCA) score Follow-up Assessments Week 10 (Induction phase endpoint): Endoscopy, histology, laboratory tests. Week 48 (Maintenance phase endpoint): Same assessments as baseline. Microbiome Analysis: Fecal samples collected at baseline, 10 weeks, and 48 weeks for metagenomics and metabolomics Safety Monitoring Adverse events graded using CTCAE criteria (Grade 1-5). Serious adverse events (SAEs) include hospitalization, disability, or life-threatening conditions Data Management Data is collected using paper Case Report Forms (CRF's) and then data will be entered in REDCap. Endoscopic images and videos are securely stored and centrally reviewed.

Effect of Perioperative Oral Rifaximin on Early Graft Dysfunction in Adult Living Donor Liver Transplant

Methodology: - Study population: All patients undergoing adult living donor liver transplant recipients - Study design: Open label Randomized control Study - Study period: After ethical board clearance, all LDLT recipients satisfying inclusion criteria till June 2025 - Sample size: n=100 - Intervention: Preoperative Rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7 - Monitoring and assessment: Not valid - Adverse effects: No adverse effect is expected to occur out of study protocols. except vomiting, headache, dizziness, nausea - Stopping rule Not valid (b) Expected outcome of the project: Perioperative oral rifaximin decreases early allograft dysfunction in recipients of adult living donor liver transplant. (c) Ethical issues in the study and plans to address these issues: None expected

Efficacy of New Post Kasai ILBS Protocol in Biliary Atresia.

Study population : Subject undergoing Kasai Sx at Institute of Liver and Biliary Sciences would be enrolled and will include retrospective historical cohort (Jan 2015 to Dec 2017) and retrospective + prospective cohort with new protocol (Jan 2018 till June 2024). Study design: Cohort study with historical control ( Jan 2015- Dec 2017) Sample size: Time bound. All cases presenting during the study period will be included in the study. Monitoring and assessment: Liver function test, Hemogram and International Normalised Ratio (INR) would be done weekly for one month, twice weekly for 2nd month and monthly thereafter till 1 year. Statistical Analysis: Appropriate statistical test for correlation analysis will be applied. Adverse effects: As per previous studies done , no serious adverse effect has been noted in treatment group vs control group.

Safety and Adequacy of Trans-jugular Liver Biopsy in Patients With Liver Disease: SAFE-TJLB Study

Hypothesis: Trans-jugular liver biopsy is safe, gives adequate sample for pathological examination in patients with liver disease. Aim of study: To evaluate safety and adequacy of trans-jugular liver biopsy in patient with liver disease. Primary objective: 1. Adequacy of trans-jugular liver biopsy 2. Safety of trans-jugular liver biopsy Secondary objective: 1. Indications of liver biopsy 2. Procedural time (in and out of catheter) 3. Number of passes 4. Failure rate 5. Day care time 6. VAS: pain (Abdomen and Neck, pre and post procedure) 7. Complications- arrythmia, hematoma 8. Time of Fluro exposure Patients and methods Study Design A prospective, observational cohort study will be conducted in patients with suspected or known liver disease between November 2023 to May 2024 at the Institute of Liver and Biliary Sciences (ILBS), New Delhi. Clinical protocol An informed consent was taken from patients with liver disease undergoing liver biopsy as per clinical indication. The following demographic data was recorded at inclusion: Age, gender, co-morbidities, type, and etiology of liver disease. Laboratory parameters include complete blood count, liver function tests, kidney function tests, INR. Severity of liver disease (MELD score, CTP score, AARC score).

Effect of Laser Photobiomodulation in Improving Mouth Opening in Oral Submucous Fibrosis

Study design: A patient and outcome assessor blinded, multiple- arm, randomized, placebo controlled clinical trial Setting: All India Institute of Medical sciences New Delhi Selection of patients: Consecutive patients diagnosed with Oral Submucous Fibrosis based on WHO clinical criteria (Warnakulsurya et al 2007, 2021) and classified as Moderate Oral Submucous Fibrosis based on functional staging of More et al 2011 (Functional staging M2 and M3: maximal interincisal distance 15-35 mm) will be prospectively recruited after ethical clearance and informed written consent. Clinicopathologic characteristics: The clinical demographics, Tobacco and Areca nut habit history ( Type, quantity, frequency, duration), association with other habits like smoking/ smokeless tobacco with/ without slaked lime, alcohol and addictive drugs will be recorded. The clinical characteristics and staging/grading of OSMF would be recorded as per prepared proforma and protocol. The clinical grading of moderate OSMF will be done according to WHO clinical criteria and More et al 2011 classification. Biopsy of any suspicious oral lesions if found will be done to rule out malignancy and referred to the cancer center for further management and excluded from study. Enrolment of subjects fulfilling the inclusion and none of the exclusion criteria will be done after information and written informed consent before any further investigation. Routine blood investigations to rule out common systemic conditions ( CBC, Blood glucose, LFT, KFT) Participants will be randomized into three arms (1:1:1) Group A: Photobiomodulation therapy (parameters defined below) given intraorally on bilateral buccal mucosa and extraorally (sham) with conventional non-invasive management. Group B: Photobiomodulation therapy (parameters defined below) given intraorally (bilateral buccal mucosa) and extraorally (bilateral masseter muscle) with conventional non-invasive management. Group C: Sham (Use of laser handpiece with only red guide light and without using the foot pedal which activates the laser)Photobiomodulation therapy(Placebo) (Intraoral and Extraoral) with conventional non-invasive management. Randomization: Block randomization with varying block size will be done using computer generated random numbers using the Nquery software. Allocation concealment: Participants will be randomized using sequentially numbered, opaque sealed envelopes (SNOSE). 315 white envelopes will be prepared with aluminum foil sheet and carbon sheet in each. Assigned treatment protocol will be mentioned clearly on a paper and put in each envelope. For each treatment protocol 105 envelopes will be prepared and sealed. Each envelope will have an identifier of trial on its front. Envelopes will be opened sequentially by an operator blinded to the study protocol after which patients will be allotted a study arm as per the treatment mentioned in the envelope. Before opening the envelope we will write the patient's study identifier number, date and operator's signature in front of the envelope, which will be transferred on white paper through carbon paper. Used envelopes will be stored separately until the completion of trial. Blinding: The subjects will be blinded to the group assignment as they will receive PBM ( Active or Sham as per group assignment ) both intraorally and extraorally The outcome assessor will be blinded to the group assignment of the subjects as they will be identified by unique randomization code only Conventional non-invasive management (Usual care): All subjects in the three groups will receive the same standard conventional non- invasive management advised for moderate OSMF as per current scientific evidence. Brief behavioral Tobacco, areca nut and alcohol habit cessation counseling as per WHO 5As and 5Rs technique at baseline and each follow up. Oral prophylaxis Removal of oral irritational factors like sharp teeth, appliances or prosthesis, impacted buccoverted third molars, parafunctional habits Oral hygiene maintenance instructions Oral physiotherapy(Mouth opening and cheek ballooning exercises) Control of systemic conditions (Anemia, Diabetes, hypertension, thyroid disorders) by specialist referral Removal of all predisposing factors for oral candida infection Advocacy for safe sexual practices Nutrition and diet counseling( seasonal and regional food rich in nutrients, vitamins, antioxidants avoidance of spicy /sour/ hot foods and drinks) Regular surveillance for malignant transformation Photobiomodulation Therapy (PBM therapy): PBM will be given with 940nm long infrared wavelength diode laser with following specifications Biolase Epic X Diode LASER (USFDA and CE approved) LASER Classification- IV Medium- InGaAsP Semi-Conductor Diode Wavelength- 940+10nm Maximum Output Power= 10W Pulse repetition rate= upto 20kHz Pulse duration Rate= 0.01ms- 20ms Power modes- Continuous/ Pulsed Protocol for PhotoBioModulation( PBM) therapy Protocol for PBM therapy has been made as per guidelines of the consensus statement ( Zelcha et al 2016) regarding the applications, protocols, safety, dosimetric considerations of PBM in management of side effects of chemoradiation therapy in Head and neck cancers like mucositis and fibrosis. Protective laser wavelength specific eyewear will be used for patient, operator. The device will be used according to the manufacturer's instructions and calibration before each therapy in the trial. The surgical handpiece (diameter 0.6cm) will be used without the fibre optic tips in defocused mode and head sanitized before therapy. Peak Power : 0.3Watts Power density: 1 Watt/cm2 Fluence: 4J/cm2 per cycle Spot size : 0.28cm2 Distance : 2mm from surface Mode: Continuous, Non- contact mode, circular motion, overlapping, in clockwise concentric manner with laser handpiece perpendicular to surface Duration of cycle : 20 seconds with interval of 30 seconds alternating with other side Cycles per sitting: Three for each side Four Sittings: Day 0,3, 7, and 15 Intraoral: Bilateral buccal mucosa will be divided arbitrarily into three zones superior, middle and inferior for equal distribution of laser energy during each cycle Extraoral :Bilateral masseter muscle will be divided into three zones superior, middle and inferior for equal distribution of laser energy during each cycle Therapeutic monitoring: Site of application of LASER will be evaluated continuously for any discomfort, signs of inflammation like redness of skin/ mucosa during therapy and during follow up. The following options will be considered during therapy Move the Handpiece relative to the affected anatomy. Defocus the energy by moving the Handpiece further away from the skin. Decrease the power setting.(considering the Fitzpatrick Skin type scale) Stop/ Defer the treatment. Patient will be interviewed to know any adverse effects they might be feeling after initiation of treatment with Laser. Training of operators: All the operators giving intraoral and extraoral PBM therapy will be trained in the protocol as per study before subject recruitment. Withdrawal criteria: If any patient withdraws consent after treatment is initiated or develops any of the conditions mentioned in exclusion criteria, the patient will be withdrawn from the study. Protocol Deviation : When/If subjects develop changes suspicious of malignancy (erosion, ulceration, induration, exophytic growth) during follow up after Usual care/PBM, they will undergo incisional biopsy to rule out malignant changes and managed as per institutional protocol for oral malignant lesions by referral to cancer center at IRCH. Statistical Analysis: Data will be entered in an electronic data form and managed using Research Electronic Data Capture (REDcap) software. Comparison of baseline continuous variables will be compared between the two groups( A and C, B and C) using Unpaired T-test and categorical variables will be compared using Chi Squared Test or Fisher's Exact Test. The primary outcome measure- Interincisal Distance at maximum mouth opening will be compared between the two groups using Unpaired T-test and analyzed using Intention to Treat and Per Protocol Analysis. Secondary continuous outcome variables will be compared between the two groups using Unpaired T-test or Wilcoxon Rank Test as appropriate. Secondary categorical outcome variables will be compared between the two groups for two proportions/Z-test. Comparison between primary and secondary outcome variables between groups A and B will also be done using the same scheme although the sample size is not estimated for the same. Results will be presented as Difference in Means/Proportions with 95% confidence interval and p<0.05 will be considered statistically significant.

FMT for Alcohol Use Disorder in Cirrhotics.

Hypothesis :- - FMT is useful in reducing craving and return to heavy drinking in patients with alcohol related cirrhosis with active drinking, through modulation of gut microbiota and correction of dysbiosis Aim and Objective - - To assess the efficacy of FMT in decreasing lapse, relapses and maintaining alcohol abstinence in AUD in patients with cirrhosis Study population: - Patients with cirrhosis with recent alcohol use attending outpatient clinic at ILBS, New Delhi Study design: - Open label, parallel group, randomized, controlled study. Study period: - 1 year Sample size with justification: - Assuming that abstinence in Placebo group is 50% and we assume that there will be 40% absolute increase in FMT group (90%; Bajaj JS, Hepatology 2021) with alpha 5 and power of 80%, investigator need to enroll 48 cases, further assuming 10 % dropout rate it was decided to enroll 54 cases that is 27 in each group.