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Irritable Bowel Syndrome With DiarrheaNCT06543498

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

A study testing Lactulose/Mannitol Ratio Test, Serum biomarkers of intestinal permeability and Rome IV questionnaire in people with Irritable Bowel Syndrome With Diarrhea, run by Dr Anthony Hobson at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Irritable Bowel Syndrome With Diarrhea
What is being tested?
Lactulose/Mannitol Ratio Test, Serum biomarkers of intestinal permeability and Rome IV questionnaire
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
2 sitesUnited Kingdom
Study dates
1 Aug 2024to 13 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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
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  • 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.
  • Gastrointestinal infection in the past 4 weeks.
  • Any other condition, deemed by the investigator, that may be causing their symptoms.
  • Participant is involved in this study as an Investigator, sub-Investigator, study coordinator, other study staff, or Sponsor member.
  • 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.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • The Functional Gut Clinic

    London, NW1 6PU

  • The Functional Gut Clinic

    Manchester, M3 4BG

Other trials in United Kingdom

About this study

Official title: 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

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.

Read more

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.

Being tested
Lactulose/Mannitol Ratio Test, Serum biomarkers of intestinal permeability, Rome IV questionnaire, Irritable bowel severity scoring system, Bowel Habit diary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lactulose/Mannitol Ratio TestDiagnostic test

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

  • Serum biomarkers of intestinal permeabilityDiagnostic test

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

  • Rome IV questionnaireOther

    Diagnositic questionnaire for IBS-D

  • Irritable bowel severity scoring systemOther

    Questionnaire to determine severity of abdominal and bowel symptoms

  • Bowel Habit diaryOther

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

  • 3 day dietary recordOther

    Used to verify compliance to exclusion criteria #5.

  • NCT and NFTDietary supplement

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

  • PlaceboOther

    Placebo supplement taken once per day.

Study groups in NCT06543498
Study groupRoleWhat they receive
NCT and NFTActive comparator21 days of 1x capsule per day. Dosage 120mg.
Receives: 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
PlaceboPlacebo comparator21 days of 1x placebo capsule per day
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in intestinal permeability

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

    Measured: Day 0 vs Day 21

Secondary outcomes (17)

  1. Serum LPS

    Comparison of start to end of study between active and placebo groups

    Measured: Day 0 vs Day 21

  2. Serum LPB

    Comparison of start to end of study between active and placebo groups

    Measured: Day 0 vs Day 21

  3. Serum sCD14

    Comparison of start to end of study between active and placebo groups

    Measured: Day 0 vs Day 21

  4. Serum Zonulin

    Comparison of start to end of study between active and placebo groups

    Measured: Day 0 vs Day 21

  5. Serum Occludin

    Comparison of start to end of study between active and placebo groups

    Measured: Day 0 vs Day 21

  6. Serum LCN12

    Comparison of start to end of study between active and placebo groups

    Measured: Day 0 vs Day 21

  7. Rescue medication

    Use of rescue medication - number of days required during treatment period first week vs last week.

    Measured: Mean Day 0-6 vs Mean Day 15-21

  8. Loperamide utilisation

    Difference between active and placebo groups

    Measured: Mean Day 0-6 vs Mean Day 15-21

  9. 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.

    Measured: Day 0 vs Day 21

  10. Stool consistency

    Average number of days of Bristol stool scale 6-7 stools during screening vs treatment period

    Measured: Day -14 to -1 vs Day 0 to 21

  11. Stool consistency

    Average number of days of Bristol stool scale 6-7 stools comparison of first vs last week of treatment period

    Measured: Mean Day 0-6 vs Mean Day 15-21

  12. Stool frequency

    Comparison of mean number of bowel movements per day screening vs treatment period.

    Measured: Day -14 to -1 vs Day 0 to 21

  13. Stool frequency

    Comparison of mean number of bowel movements per day first vs last week of treatment period.

    Measured: Mean Day 0-6 vs Mean Day 15-21

  14. Bloating

    Comparison of mean daily bloating score screening vs treatment period. Minimum score is 0, Maximum score is 3. Higher score indicates more symptoms.

    Measured: Day -14 to -1 vs Day 0 to 21

  15. 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.

    Measured: Mean Day 0-6 vs Mean Day 15-21

  16. 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.

    Measured: Day -14 to -1 vs Day 0 to 21

  17. 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.

    Measured: Mean Day 0-6 vs Mean Day 15-21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start1 Aug 2024
  3. Primary completion13 Jan 2025
  4. Study completion13 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06543498
Sponsor's protocol ID
FGC-24-003
Status last verified
Jun 2025
First submitted
23 Jul 2024
Last updated
24 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Lactulose/Mannitol Ratio Test, Serum biomarkers of intestinal permeability and Rome IV questionnaire in people with Irritable Bowel Syndrome With Diarrhea, run by Dr Anthony Hobson at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in intestinal permeability (time frame: Day 0 vs Day 21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06543498.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.

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