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

NCT06543498 | Completed

• 1 other identifier: FGC-24-003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in intestinal permeability

  Lactulose mannitol ratio change in urine from baseline to end of treatment

  Day 0 vs Day 21

Secondary Outcomes (17)

• Serum LPS

  Day 0 vs Day 21

• Serum LPB

  Day 0 vs Day 21

• Serum sCD14

  Day 0 vs Day 21

• Serum Zonulin

  Day 0 vs Day 21

• Serum Occludin

  Day 0 vs Day 21

Study Arms (2)

NCT and NFT

ACTIVE COMPARATOR

21 days of 1x capsule per day. Dosage 120mg.

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

Placebo

PLACEBO COMPARATOR

21 days of 1x placebo capsule per day

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; Other: Placebo

Interventions

Lactulose/Mannitol Ratio Test DIAGNOSTIC_TEST

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

NCT and NFT; Placebo

Serum biomarkers of intestinal permeability DIAGNOSTIC_TEST

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

NCT and NFT; Placebo

Rome IV questionnaire OTHER

Diagnositic questionnaire for IBS-D

NCT and NFT; Placebo

Irritable bowel severity scoring system OTHER

Questionnaire to determine severity of abdominal and bowel symptoms

NCT and NFT; Placebo

Bowel Habit diary OTHER

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

NCT and NFT; Placebo

3 day dietary record OTHER

Used to verify compliance to exclusion criteria #5.

NCT and NFT; Placebo

NCT and NFT DIETARY_SUPPLEMENT

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

NCT and NFT

Placebo OTHER

Placebo supplement taken once per day.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Prior abdominal surgery other than appendectomy, tubal ligation, hysterectomy or cholecystectomy.
• Participated in a trial of an investigational medical product or medical device in the 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. Participant should 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.

Sponsors & Collaborators

• Dr Anthony Hobson: lead

Study Sites (2)

The Functional Gut Clinic

London, NW1 6PU, United Kingdom

Location

The Functional Gut Clinic

Manchester, M3 4BG, United Kingdom

Location

MeSH Terms

Interventions

Diet Records

Intervention Hierarchy (Ancestors)

Records; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: August 9, 2024
• Study Start: August 1, 2024
• Primary Completion: January 13, 2025
• Study Completion: January 13, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)