To Study the Efficacy and Safety of L. Plantarum UALp-05TM in Diarrhea- Predominant-irritable Bowel Syndrome

Last updated: July 8, 2022
Sponsor: Vedic Lifesciences Pvt. Ltd.
Overall Status: Completed

Phase

N/A

Condition

Bowel Dysfunction

Fecal Incontinence

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT04950296
UAS201003/LPLANTARUMUALP05IBS
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Several probiotic strains have shown beneficial outcomes in IBS patients, particularly among the Lactobacillus and Bifidobacterium genera, Lactobacillus plantarum (recently reclassified as Lactiplantibacillus plantarum) is a frequently isolated species of the healthy human GI tract that has been studied in numerous GI clinical studies, including for IBS.In the present study, the efficacy and tolerability of L. plantarum (UALp-05TM), will be evaluated in individuals with IBS-D.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Males and females aged 18 to 70 years.
  2. Participants with Irritable bowel syndrome (IBS) as per Rome IV IBS criteria: Recurrent abdominal pain on average at least 1 day/week in the last 3 months,associated with two or more of the following criteria:
  • Related to defecation (Maybe increased or decreased by defecation)
  • Associated with a change in the frequency of stool (increase in frequency)
  • Associated with a change in the form (appearance) of stool
  1. History of abnormal bowel movements, which are predominantly diarrhea (more thanone-fourth (25%) of bowel movements with BSS Types 6-7 and less than one-fourth (25%)with BSS Types 1-2) in the last one month prior to screening.
  2. Average APS-NRS score of ≥ 6 for last 3 months prior to screening visit.
  3. Fasting blood glucose levels ≤ 125 mg/dL (6.94 mmol/l).
  4. Hemoglobin ≥ 10 g/dL.
  5. Able to comply and perform the procedures requested by the protocol (consumption ofstudy medications, filling scheduled eDiary for health updates, biological samplecollection procedures and study visit schedule).
  6. Participants with access to western toilet facilities.
  7. Participants with non-vegetarian dietary preferences (Note: Non-vegetarian food willbe defined as food derived from animals, birds, fish, shell-fish, etc)
  8. Participants consuming non-vegetarian food for at least 2 times in a week.
  9. SpO2 ≥ 96% as assessed by fingertip pulse oximetry
  10. Participants who are sufficiently literate to understand the essence of the study, areinformed about the purpose of the study, and understand their rights.
  11. Participants who are able to give written informed consent and are willing toparticipate in the study.

Exclusion

Exclusion Criteria:

  1. Participants not meeting IBS-D diagnostic criteria (i.e. IBS-Constipation, Mixed orUnclassified).
  2. Uncontrolled abnormal Thyroid Stimulating Hormone (TSH) value which is < 0.35 or > 4.94 μIU/mL.
  3. Uncontrolled Type II DM (Controlled Type II diabetics can be included uponinvestigator's discretion).
  4. Type I diabetes.
  5. Uncontrolled hypertension defined as SBP ≥ 140 mm Hg and/or DBP ≥ 90 mm Hg.
  6. Use of probiotics and/or prebiotics (In the form of supplements) within the last 4weeks prior to screening.
  7. Use of medicines (Prescription, OTC, etc), health supplements or herbal medicinesexpected to promote gut health and alleviate IBS related complications within the lastfour 4 months prior to screening.
  8. Established diagnosis of Helicobacter pylori infection in last 3 months prior toscreening.
  9. History of surgical resection of the stomach, small intestine or large intestine.
  10. Participants with acute gastroenteritis.
  11. History or complications of inflammatory bowel disease (Crohn's disease or ulcerativecolitis) or ischemic colitis.
  12. Participants with complications from infectious enteritis.
  13. History of any diet-based intolerance (gluten or lactose intolerance).
  14. History of or complications from malignant tumors.
  15. History of any significant neurological or psychiatric condition which may affectstudy participation or inference of study outcomes.
  16. Consumption of psychotropic agents in the last 1 year prior to screening.
  17. History (in past 2 years) of smoking or currently smoking or using any form ofsmokeless tobacco.
  18. Participation in other clinical trials in last 90 days prior to screening.
  19. Participants with heavy alcohol consumption, defined as:
  • For men: More than 14 standard alcoholic drinks (SAD)/week or more than 4 SAD ina day.
  • For women: More than 7 SAD/week or more than 3 SAD in a day. (NOTE - A standardalcoholic drink contains approximately 14 grams of alcohol, which is equivalentto 12 ounces of beer (5% alcohol), 8.5 ounces of malt liquor (9% alcohol), 5ounces of wine (~12% alcohol), 3.5 ounces of fortified wine (e.g., sherry orport), or 1.5 ounces of liquor (distilled spirits; ~40% alcohol).
  1. Participants who have a clinically active state of systemic illness, which may includebut is not limited to cardiovascular, endocrine, immune, respiratory, hepatobiliary,kidney and genitourinary, neuropsychiatric, and gastrointestinal system. To be ruledout by physician based on prior history and physical examination.
  2. Females who are pregnant/planning to be pregnant/lactating or taking any oralcontraceptives.
  3. Any condition that could, in the opinion of the investigator, preclude theparticipant's ability to successfully and safely complete the study or that mayconfound study outcomes.

Study Design

Total Participants: 314
Study Start date:
September 16, 2021
Estimated Completion Date:
May 05, 2022

Study Description

Several strains of Lactobacillus genus have previously been assessed in patients with IBS in multiple randomized controlled trials, demonstrating the efficacy of these strains in reducing IBS-related symptoms such as abdominal pain, distension and flatulence. We hypothesize the L. plantarum UALp-05 strain to benefit research participants by reducing pain severity, normalizing diarrhea predominant stool type and subsequently improving quality of life (QOL) standards. The current study with L. plantarum UALp-05, will include a lower dose of 1 billion CFU/day (considered a low dose among probiotic IBS studies) and a higher dose of 10 billion CFU/ day (considered a mid-point dose among probiotic IBS studies) for a period of 8-weeks.Each probiotic dosage group will be assessed individually in comparison to placebo.

Connect with a study center

  • Ahmedabad Gastro Associates,

    Ahmedabad, Gujarat 380061
    India

    Site Not Available

  • Apex Gastro Clinic and Hospital,

    Ahmedabad, Gujarat 380013.
    India

    Site Not Available

  • SN Gastro and Liver Clinic

    Ahmedabad, Gujarat 380054
    India

    Site Not Available

  • Aman Hospital and research center

    Vadodara, Gujarat -390021.
    India

    Site Not Available

  • Dr. Khanna Clinic,

    Mumbai, Maharashtra 400059
    India

    Site Not Available

  • My Health Clinic,

    Mumbai, Maharashtra 400059.
    India

    Site Not Available

  • Samarth Digestive Disease Centre

    Mumbai, Maharashtra 400705,
    India

    Site Not Available

  • Stress Test Clinic

    Mumbai, Maharashtra 400059
    India

    Site Not Available

  • Rahate Surgical Hospital,

    Nagpur, Maharashtra 440008.
    India

    Site Not Available

  • Ashirwad Hospital And Research Centre,

    Ulhasnagar, Maharashtra 421004
    India

    Site Not Available

  • Shubham Sudbhawana Superspeciality Hospital,

    Varanasi, Uttar Pradesh 221005.
    India

    Site Not Available

  • Khannas Clinic

    Varanasi ., Uttar Pradesh 221010
    India

    Site Not Available

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