The Effect of Dietary Supplementation on Intestinal Barrier Function in IBS-D

Phase

N/A

Condition

Lactose Intolerance

Colic

Bowel Dysfunction

Treatment

Rome IV questionnaire

NCT and NFT

Serum biomarkers of intestinal permeability

Clinical Study ID

NCT06543498

FGC-24-003

Ages 18-70
All Genders

Study Summary

Many people suffer from Irritable Bowel Syndrome (IBS) every year in the UK. Depending on the stool consistency, IBS can be classified as IBS with diarrhoea (IBS-D), IBS with constipation (IBS-C), or mixed IBS (IBS-M). Around 24% of those suffering with IBS have the diarrhoea variant.

IBS-D has been shown to greatly impact sufferers' quality of life and there is currently a lack of well tolerated therapies to treat this condition. Therefore, it is of upmost important to find safe and effective non-pharmacological treatments for this condition.

Two natural compounds which may interact with the body NCT and NFT have been identified in a range of edible sources and can be involved in processes that help maintain an effective gut barrier and therefore potentially help treat a leaky gut.

This research study aims to examine the effectiveness of these compounds, NCT and NFT in combination compared to a placebo (capsule that looks the same as the study product but contains no active study ingredient) capsule on gut barrier function in individuals suffering from IBS-D.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Participant has provided written informed consent before participating in the studyafter being given a full description of the study and prior to any study-specificprocedures being performed.
Participant has irritable bowel syndrome with diarrhoea (IBS-D), as defined by theRome IV criteria, confirmed by bowel diary.
Participant has an IBS-SSS score of >175
LPS at screening >0.21 ng/ml.
Participant is a male or non-pregnant female and is 18-70 years of age
If WOCBP participant is willing to adhere to one of the following methods ofcontraception i) Hormonal contraception e.g. the 'pill' or an implant ii)Intrauterine device (IUD) iii) Intrauterine hormone-releasing system (IUS) iv)Hysterectomy v) Vasectomised partner vi) Sexual abstinence (if it is in line withyour preferred and usual lifestyle).
Participant can communicate well with the Investigator and to comply with therequirements for the entire study.
Participant has capacity to understand written English.
Participant has a body mass index (BMI) of 18.5 - 39.9kg/m2 (bounds included).
Participant agrees to follow all pre-test preparation before L/M testing.

Exclusion

Exclusion Criteria:

Prior abdominal surgery other than appendectomy, tubal ligation, hysterectomy orcholecystectomy.
Participated in a trial of an investigational medical product or medical device inthe last 28 days.
Females who report to be pregnant or lactating
Unwilling to maintain stable doses of permitted concomitant medication.
Unwilling to maintain a stable diet for the duration of the trial.
Being in the opinion of the investigator unsuitable
Insufficient knowledge of English to complete the daily bowel diary and food diary.
Hypersensitivity to any component of the supplement
Hypersensitivity or known allergy to lactulose or mannitol.
Consumption of oral antibiotics in the last 2 weeks.
NSAIDs for 2 weeks prior to and during the entire 21 day study period. Participantshould not be a chronic NSAID user (>1 day/week).
Participants who have received bowel preparation for investigative procedures in the 4 weeks prior to the study.
Diabetes mellitus (type 1).
Participants with known hepatic disease.
Inflammatory bowel disease (Crohn's/Colitis) or coeliac disease.
Gastrointestinal infection in the past 4 weeks.
Any other condition, deemed by the investigator, that may be causing their symptoms.
Participant is involved in this study as an Investigator, sub-Investigator, studycoordinator, other study staff, or Sponsor member.
Participant is unable to adhere to withholding in endurance exercise, such as >45minutes of high intensity running, cycling, rowing etc, from the screening phonecall to the end of study visit.

Study Design