The Effect of Dietary Supplementation on Intestinal Barrier Function in IBS-D
NCT Number: NCT06543498
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Irritable Bowel Syndrome With Diarrhea
Interventions: DIAGNOSTIC_TEST: Lactulose/Mannitol Ratio Test|DIAGNOSTIC_TEST: Serum biomarkers of intestinal permeability|OTHER: Rome IV questionnaire|OTHER: Irritable bowel severity scoring system|OTHER: Bowel Habit diary|OTHER: 3 day dietary record|DIETARY_SUPPLEMENT: NCT and NFT|OTHER: Placebo
Sponsor: Dr Anthony Hobson
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-02

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.

Primary Outcome Measures: Change in intestinal permeability, Lactulose mannitol ratio change in urine from baseline to end of treatment, Day 0 vs Day 21
Secondary Outcome Measures: Serum LPS, Comparison of start to end of study between active and placebo groups, Day 0 vs Day 21|Serum LPB, Comparison of start to end of study between active and placebo groups, Day 0 vs Day 21|Serum sCD14, Comparison of start to end of study between active and placebo groups, Day 0 vs Day 21|Serum Zonulin, Comparison of start to end of study between active and placebo groups, Day 0 vs Day 21|Serum Occludin, Comparison of start to end of study between active and placebo groups, Day 0 vs Day 21|Serum LCN12, Comparison of start to end of study between active and placebo groups, Day 0 vs Day 21|Rescue medication, Use of rescue medication - number of days required during treatment period first week vs last week., Mean Day 0-6 vs Mean Day 15-21|Loperamide utilisation, Difference between active and placebo groups, Mean Day 0-6 vs Mean Day 15-21|Irritable bowel severity scoring system, Change in mean score at end of treatment vs start. Minimum score 0, maximum 500. Higher score indicates worse symptoms., Day 0 vs Day 21|Stool consistency, Average number of days of Bristol stool scale 6-7 stools during screening vs treatment period, Day -14 to -1 vs Day 0 to 21|Stool consistency, Average number of days of Bristol stool scale 6-7 stools comparison of first vs last week of treatment period, Mean Day 0-6 vs Mean Day 15-21|Stool frequency, Comparison of mean number of bowel movements per day screening vs treatment period., Day -14 to -1 vs Day 0 to 21|Stool frequency, Comparison of mean number of bowel movements per day first vs last week of treatment period., Mean Day 0-6 vs Mean Day 15-21|Bloating, Comparison of mean daily bloating score screening vs treatment period. Minimum score is 0, Maximum score is 3. Higher score indicates more symptoms., Day -14 to -1 vs Day 0 to 21|Bloating, Comparison of mean daily bloating score first vs last week of treatment period. Minimum score is 0, Maximum score is 3. Higher score indicates more symptoms., Mean Day 0-6 vs Mean Day 15-21|Abdominal pain, Comparison of mean daily abdominal pain score screening vs treatment period. Minimum score is 0, Maximum score is 3. Higher score indicates more symptoms., Day -14 to -1 vs Day 0 to 21|Abdominal pain, Comparison of mean daily abdominal pain score first vs last week of treatment period. Minimum score is 0, Maximum score is 3. Higher score indicates more symptoms., Mean Day 0-6 vs Mean Day 15-21