CompletedNot Applicable

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

United Kingdom32 participantsStarted 2024-08-01

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Participant has provided written informed consent before participating in the study after being given a full description of the study and prior to any study-specific procedures being performed.
✓. Participant has irritable bowel syndrome with diarrhoea (IBS-D), as defined by the Rome 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 of contraception 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 with your preferred and usual lifestyle).
✓. Participant can communicate well with the Investigator and to comply with the requirements for the entire study.
✓. Participant has capacity to understand written English.

Exclusion criteria

What they're measuring

Change in intestinal permeability

Timeframe: Day 0 vs Day 21

Trial details

NCT IDNCT06543498

SponsorDr Anthony Hobson

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-13

View on ClinicalTrials.gov More Irritable Bowel Syndrome With Diarrhea trials