NCT06543498

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

Pilot Study - The Effect of Bioactive Compounds N-trans-Caffeoyltyramine (NCT) and N-trans-Feruloyltyramine (NFT) on Intestinal Barrier Function in Participants With Irritable Bowel Syndrom With Diarrhoea

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Dr Anthony Hobson · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-01-13
• Completion: 2025-01-13
• First posted: 2024-08-09
• Last updated: 2025-06-24

Locations

2 sites across 1 country: United Kingdom