Lactulose/Mannitol Ratio Test
Diagnostic TestTo test for gut permeability, Urine collected over 8hrs after ingestion of lactulose/mannitol drink.
NCT Number: NCT06543498
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
The Functional Gut Clinic, London, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
To test for gut permeability, Urine collected over 8hrs after ingestion of lactulose/mannitol drink.
Phlebotomy and subsequent lab tests to analyse concentration of LPS, LPB, sCD14, Zonulin and Occludin.
Diagnositic questionnaire for IBS-D
Questionnaire to determine severity of abdominal and bowel symptoms
Assess bowel habit at baseline and changes in bowel habit over the study
Used to verify compliance to exclusion criteria #5.
N-transcaffeoyltyramine and N-transferuloyltyramine supplement taken once per day.
Placebo supplement taken once per day.
Time frame: Day 0 vs Day 21
Lactulose mannitol ratio change in urine from baseline to end of treatment
Time frame: Day 0 vs Day 21
Comparison of start to end of study between active and placebo groups
Time frame: Day 0 vs Day 21
Comparison of start to end of study between active and placebo groups
Time frame: Day 0 vs Day 21
Comparison of start to end of study between active and placebo groups
Time frame: Day 0 vs Day 21
Comparison of start to end of study between active and placebo groups
Time frame: Day 0 vs Day 21
Comparison of start to end of study between active and placebo groups
Time frame: Day 0 vs Day 21
Comparison of start to end of study between active and placebo groups
Time frame: Mean Day 0-6 vs Mean Day 15-21
Use of rescue medication - number of days required during treatment period first week vs last week.
Time frame: Mean Day 0-6 vs Mean Day 15-21
Difference between active and placebo groups
Time frame: Day 0 vs Day 21
Change in mean score at end of treatment vs start. Minimum score 0, maximum 500. Higher score indicates worse symptoms.
Time frame: Day -14 to -1 vs Day 0 to 21
Average number of days of Bristol stool scale 6-7 stools during screening vs treatment period
Time frame: Mean Day 0-6 vs Mean Day 15-21
Average number of days of Bristol stool scale 6-7 stools comparison of first vs last week of treatment period
Time frame: Day -14 to -1 vs Day 0 to 21
Comparison of mean number of bowel movements per day screening vs treatment period.
Time frame: Mean Day 0-6 vs Mean Day 15-21
Comparison of mean number of bowel movements per day first vs last week of treatment period.
Time frame: Day -14 to -1 vs Day 0 to 21
Comparison of mean daily bloating score screening vs treatment period. Minimum score is 0, Maximum score is 3. Higher score indicates more symptoms.
Time frame: Mean Day 0-6 vs Mean Day 15-21
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.
Time frame: Day -14 to -1 vs Day 0 to 21
Comparison of mean daily abdominal pain score screening vs treatment period. Minimum score is 0, Maximum score is 3. Higher score indicates more symptoms.
Time frame: Mean Day 0-6 vs Mean Day 15-21
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.
Dr Anthony Hobson
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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