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

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.

Conditions

• Irritable Bowel Syndrome With Diarrhea

Interventions

DIAGNOSTIC_TEST

Lactulose/Mannitol Ratio Test

To test for gut permeability, Urine collected over 8hrs after ingestion of lactulose/mannitol drink.

DIAGNOSTIC_TEST

Serum biomarkers of intestinal permeability

Phlebotomy and subsequent lab tests to analyse concentration of LPS, LPB, sCD14, Zonulin and Occludin.

OTHER

Rome IV questionnaire

Diagnositic questionnaire for IBS-D

OTHER

Irritable bowel severity scoring system

Questionnaire to determine severity of abdominal and bowel symptoms

OTHER

Bowel Habit diary

Assess bowel habit at baseline and changes in bowel habit over the study

OTHER

3 day dietary record

Used to verify compliance to exclusion criteria #5.

DIETARY_SUPPLEMENT

NCT and NFT

N-transcaffeoyltyramine and N-transferuloyltyramine supplement taken once per day.

OTHER

Placebo

Placebo supplement taken once per day.

Sponsors & Collaborators

• Dr Anthony Hobson

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-01

Primary Completion

2025-01-13

Completion

2025-01-13

Countries

• United Kingdom

Study Locations