The Effect of Dietary Supplementation on Intestinal Barrier Function in IBS-D
NCT ID: NCT06543498
Last Updated: 2025-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2024-08-01
2025-01-13
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NCT and NFT
21 days of 1x capsule per day. Dosage 120mg.
Lactulose/Mannitol Ratio Test
To test for gut permeability, Urine collected over 8hrs after ingestion of lactulose/mannitol drink.
Serum biomarkers of intestinal permeability
Phlebotomy and subsequent lab tests to analyse concentration of LPS, LPB, sCD14, Zonulin and Occludin.
Rome IV questionnaire
Diagnositic questionnaire for IBS-D
Irritable bowel severity scoring system
Questionnaire to determine severity of abdominal and bowel symptoms
Bowel Habit diary
Assess bowel habit at baseline and changes in bowel habit over the study
3 day dietary record
Used to verify compliance to exclusion criteria #5.
NCT and NFT
N-transcaffeoyltyramine and N-transferuloyltyramine supplement taken once per day.
Placebo
21 days of 1x placebo capsule per day
Lactulose/Mannitol Ratio Test
To test for gut permeability, Urine collected over 8hrs after ingestion of lactulose/mannitol drink.
Serum biomarkers of intestinal permeability
Phlebotomy and subsequent lab tests to analyse concentration of LPS, LPB, sCD14, Zonulin and Occludin.
Rome IV questionnaire
Diagnositic questionnaire for IBS-D
Irritable bowel severity scoring system
Questionnaire to determine severity of abdominal and bowel symptoms
Bowel Habit diary
Assess bowel habit at baseline and changes in bowel habit over the study
3 day dietary record
Used to verify compliance to exclusion criteria #5.
Placebo
Placebo supplement taken once per day.
Interventions
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Lactulose/Mannitol Ratio Test
To test for gut permeability, Urine collected over 8hrs after ingestion of lactulose/mannitol drink.
Serum biomarkers of intestinal permeability
Phlebotomy and subsequent lab tests to analyse concentration of LPS, LPB, sCD14, Zonulin and Occludin.
Rome IV questionnaire
Diagnositic questionnaire for IBS-D
Irritable bowel severity scoring system
Questionnaire to determine severity of abdominal and bowel symptoms
Bowel Habit diary
Assess bowel habit at baseline and changes in bowel habit over the study
3 day dietary record
Used to verify compliance to exclusion criteria #5.
NCT and NFT
N-transcaffeoyltyramine and N-transferuloyltyramine supplement taken once per day.
Placebo
Placebo supplement taken once per day.
Eligibility Criteria
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Inclusion Criteria
2. Participant has irritable bowel syndrome with diarrhoea (IBS-D), as defined by the Rome IV criteria, confirmed by bowel diary.
3. Participant has an IBS-SSS score of \>175
4. LPS at screening \>0.21 ng/ml.
5. Participant is a male or non-pregnant female and is 18-70 years of age
6. 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).
7. Participant can communicate well with the Investigator and to comply with the requirements for the entire study.
8. Participant has capacity to understand written English.
9. Participant has a body mass index (BMI) of 18.5 - 39.9kg/m2 (bounds included).
10. Participant agrees to follow all pre-test preparation before L/M testing.
Exclusion Criteria
2. Participated in a trial of an investigational medical product or medical device in the last 28 days.
3. Females who report to be pregnant or lactating
4. Unwilling to maintain stable doses of permitted concomitant medication.
5. Unwilling to maintain a stable diet for the duration of the trial.
6. Being in the opinion of the investigator unsuitable
7. Insufficient knowledge of English to complete the daily bowel diary and food diary.
8. Hypersensitivity to any component of the supplement
9. Hypersensitivity or known allergy to lactulose or mannitol.
10. Consumption of oral antibiotics in the last 2 weeks.
11. 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).
12. Participants who have received bowel preparation for investigative procedures in the 4 weeks prior to the study.
13. Diabetes mellitus (type 1).
14. Participants with known hepatic disease.
15. Inflammatory bowel disease (Crohn's/Colitis) or coeliac disease.
16. Gastrointestinal infection in the past 4 weeks.
17. Any other condition, deemed by the investigator, that may be causing their symptoms.
18. Participant is involved in this study as an Investigator, sub-Investigator, study coordinator, other study staff, or Sponsor member.
19. Participant is unable to adhere to withholding in endurance exercise, such as \>45 minutes of high intensity running, cycling, rowing etc, from the screening phone call to the end of study visit.
18 Years
70 Years
ALL
No
Sponsors
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Dr Anthony Hobson
OTHER
Responsible Party
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Dr Anthony Hobson
Chief Investigator
Locations
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The Functional Gut Clinic
London, , United Kingdom
The Functional Gut Clinic
Manchester, , United Kingdom
Countries
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Other Identifiers
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FGC-24-003
Identifier Type: -
Identifier Source: org_study_id
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