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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in intestinal permeability
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Placebo
21 days of 1x placebo capsule per day
干预措施: Rome IV questionnaire (Other)
NCT and NFT
21 days of 1x capsule per day. Dosage 120mg.
干预措施: Lactulose/Mannitol Ratio Test (Diagnostic Test)
NCT and NFT
21 days of 1x capsule per day. Dosage 120mg.
干预措施: Serum biomarkers of intestinal permeability (Diagnostic Test)
NCT and NFT
21 days of 1x capsule per day. Dosage 120mg.
干预措施: Rome IV questionnaire (Other)
NCT and NFT
21 days of 1x capsule per day. Dosage 120mg.
干预措施: Irritable bowel severity scoring system (Other)
NCT and NFT
21 days of 1x capsule per day. Dosage 120mg.
干预措施: Bowel Habit diary (Other)
NCT and NFT
21 days of 1x capsule per day. Dosage 120mg.
干预措施: 3 day dietary record (Other)
NCT and NFT
21 days of 1x capsule per day. Dosage 120mg.
干预措施: NCT and NFT (Dietary Supplement)
Placebo
21 days of 1x placebo capsule per day
干预措施: Lactulose/Mannitol Ratio Test (Diagnostic Test)
Placebo
21 days of 1x placebo capsule per day
干预措施: Serum biomarkers of intestinal permeability (Diagnostic Test)
Placebo
21 days of 1x placebo capsule per day
干预措施: Irritable bowel severity scoring system (Other)
Placebo
21 days of 1x placebo capsule per day
干预措施: Bowel Habit diary (Other)
Placebo
21 days of 1x placebo capsule per day
干预措施: 3 day dietary record (Other)
Placebo
21 days of 1x placebo capsule per day
干预措施: Placebo (Other)
结局指标
主要结局
Change in intestinal permeability
时间窗: Day 0 vs Day 21
Lactulose mannitol ratio change in urine from baseline to end of treatment
次要结局
- Serum LPB(Day 0 vs Day 21)
- Serum sCD14(Day 0 vs Day 21)
- Serum Zonulin(Day 0 vs Day 21)
- Serum LCN12(Day 0 vs Day 21)
- Irritable bowel severity scoring system(Day 0 vs Day 21)
- Stool frequency(Mean Day 0-6 vs Mean Day 15-21)
- Serum LPS(Day 0 vs Day 21)
- Serum Occludin(Day 0 vs Day 21)
- Rescue medication(Mean Day 0-6 vs Mean Day 15-21)
- Abdominal pain(Mean Day 0-6 vs Mean Day 15-21)
- Loperamide utilisation(Mean Day 0-6 vs Mean Day 15-21)
- Stool consistency(Mean Day 0-6 vs Mean Day 15-21)
- Bloating(Mean Day 0-6 vs Mean Day 15-21)
- Stool consistency(Day -14 to -1 vs Day 0 to 21)
- Stool frequency(Day -14 to -1 vs Day 0 to 21)
- Bloating(Day -14 to -1 vs Day 0 to 21)
- Abdominal pain(Day -14 to -1 vs Day 0 to 21)
研究者
Dr Anthony Hobson
Chief Investigator
The Functional Gut Clinic