Mechanism of FODMAP Restriction on FGID Patients

Официальное название

Mechanism of FODMAP Restriction on Gut Microbiota and Gut Barrier Function in Functional Gastrointestinal Disorder Patients : A Randomised Controlled Trial

Обзор

Brief Summary : The goal of this clinical trial is to investigate the effects of differing FODMAP diets on gut microbiota, gut barrier function, symptom severity, quality of life, and psychological status in FGID patients. The main question it aims to answer is : How does diets with differing FODMAP content affect the gut microbiota, gut barrier function, symptom severity, psychological status and quality of life in patients with FGID ? Researchers will compare low FODMAP diet, Gentle FODMAP diet and Traditional Dietary Advice (NICE guidelines) to see which diet is more suitable and effective for Malaysian FGID patients. Participants will : Be given either low FODMAP diet, Gentle FODMAP diet or Traditional Dietary Advice intervention and will be required to follow the intervention for two weeks. Be required to provide stool and blood samples during baseline and intervention Record 4 day food diary and complete assessing questionnaires during baseline and intervention

Подробное описание

Functional Gastrointestinal Disorder (FGIDs), including irritable bowel syndrome (IBS) and functional dyspepsia (FD), are prevalent conditions that effects about 40% of world population and 21% of Malaysian population. They represent a significant health burden, impacting patients' quality of life. While the low FODMAP diet is effective in managing FGID around the western region, there is limited research done on comparing the impacts of diets with differing FODMAP content on symptom severity, quality of life, gut microbiota and gut barrier function of FGID patients in the Asian region as low FODMAP is restrictive. Therefore, conducting a randomised controlled trial is vital in measuring the effectiveness of diet with differing FODMAPs on FGID patients.

The objectives of this study are :

* To determine the effect of FODMAPs restriction on the gut microbiota abundance and diversity in FGID patients * To determine the effect of FODMAPs restriction on gut barrier function after dietary intervention among FGID patients * To determine the effect of FODMAPs restriction on the symptom severity, quality of life and psychological status in FGID patients

This study would be able to provide significant understanding of dietary management of FGID. Conducting this study would provide critical insights into the role of gut microbiota and gut barrier function in the pathophysiology of FGID, highlighting how dietary modulation can impact overall symptom management.

The study design involve screening and recruiting participants, followed by baseline data collection, randomisation, group allocation, and intervention with data collection.

First Visit (Day 1) During baseline, vital information such as socio demographic data will be gathered and FGID screening will be conducted using the ROME III Asian Diagnostic Questionnaire for Adults which consists of the Irritable Bowel Syndrome module and the Gastroduodenal Disorders module. A total of 5 questionnaires will be provide to the participants. These are Irritable Bowel Syndrome Severity Scale (IBS-SSS), Gastrointestinal Symptom Rating Scale (GSRS), Food avoidance and Dietary trigger questionnaire, Hospital Anxiety and Depression Scale (HADS), and the EQ-5D-5L questionnaire.

Body weight and composition of participants will be assessed using the Tanita Body Composition scale, whereas height of participants will be measured using a stadiometer. Dietary and FODMAPs will be estimated using a 4-day food diary (3 weekdays, 1 weekend). Additionally, blood sample will be collected from participants for further assessment. 10 ml blood will be drawn from each participant to detect serum biomarkers. Stool bottle will be provided to participants for stool collection upon the next visit. Stool collection is implemented to assess participants' gut integrity and gut microbiota. After concluding the baseline assessments, patients will be randomised into three groups. Groups A, B and C will follow a restricted FODMAP diet (LFD), Gentle FODMAP diet and traditional dietary advice (TDA), respectively. Participants will be randomly assigned to a study arm by a computer-generated randomisation program using the open-access website www.randomization.com at a ratio of 1:1:1.

Second Visit (Day 8) Participants will return their stool sample and completed diary. The diary will be assessed for completion, and the stool sample will be collected and frozen per protocol. Based on randomisation, participants in the LFD group will be provided with restricted FODMAP advice. In contrast, those in the GFD group will be given general healthy advice by dietitians/researchers trained in delivering the diet. Meanwhile, participants in the TDA group will be given an overall healthy dietary intervention and counselling. All three groups will be advised to follow their respective diets for two weeks. A food diary and another stool collection bottle will be provided.

Phone follow up (Day 15) A phone follow-up is scheduled after a week to remind participants to complete their food diary, answer any doubts or questions relating to their allocated intervention and subsequently plan their next visit.

Final visit (Day 22) Visit 3 will be scheduled after 2 weeks of intervention. Participants will return their stool samples, food diary, and questionnaire. They will also complete two symptom severity questionnaires, food avoidance and dietary trigger questionnaire, with questionnaires to assess quality of life and psychological status and provide a non-fasting blood sample. Additionally, participants in the LFD group will be provided advice on reintroduction. Those who have completed the study will be given an inconvenience allowance.

Вмешательства

• Поведенческое Low FODMAP diet
  High FODMAP foods are swapped for low FODMAP alternatives, for two weeks (Elimination phase)
• Поведенческое Gentle FODMAP diet
  Key High FODMAP foods will be identified from patients' food diaries and swapped with low FODMAP alternatives. (Elimination phase)
• Поведенческое Traditional Dietary Advice
  Subjects are required to follow a set of healthy eating guidelines set by NICE guidelines for IBS for two weeks a. Have regular meals and take time to eat b. Avoid missing meals or leaving long gaps between eating c. Drink at least eight cups of fluid a day, especially water or other non-d. caffeinated drinks, such as herbal teas d. Restrict tea and coffee to three cups a day e. Reduce intake of alcohol and fizzy drinks . Limit intake of high-fibre food g. Reduce intake of resistant starch h. Li

Первичные конечные точки

• Effect of FODMAP restrictions on Gut Microbiota Abundance and Diversity [Срок оценки: Measurement before (Day 1) and after the diet (Day 22)]
• Effect of FODMAP restrictions on Gut Barrier Function [Срок оценки: Measurement before (Day 1) and after the diet (Day 22)]

Вторичные конечные точки (7)

• Effect of 2 week FODMAP restrictions on Symptom Severity (IBS-SSS questionnaire) [Срок оценки: Measurement before (Day 1) and after the diet (Day 22)]
• Effect of 2-week FODMAP restriction on Psychological Status [Срок оценки: Measurement before (Day 1) and after the diet (Day 22)]
• Effect of 2-week FODMAP restriction on Quality of Life [Срок оценки: Measurement before (Day 1) and after the diet (Day 22)]
• Effect of 2-week FODMAP restriction on Food Avoidance [Срок оценки: Measurement before (Day 1) and after the diet (Day 22)]
• Effect of 2 week FODMAP restrictions on Anthropometry [Срок оценки: Measurement before (Day 1) and after the diet (Day 22)]
• FODMAP Intake Before and After Intervention [Срок оценки: Measurement before (Day 1) and after the diet (Day 22)]
• Effect of 2-week FODMAP restrictions on Symptom Severity (GSRS questionnaire) [Срок оценки: Measurement before (Day 1) and after the diet (Day 22)]

Критерии участия

Критерии включения

• Aged 18 and above
• Able to provide informed consent
• Those with pre-existing irritable bowel syndrome (IBS) or functional dyspepsia (FD) or both screened by gastroenterologists
• Meet the ROME III- Asian criteria for FGID
• Able to communicate in Malay or English language

Критерии исключения

• Pregnant or lactating women
• History declared by the participant of pre-existing gastrointestinal disorder, including but not limited to Inflammatory Bowel Disease, Coeliac Disease, Pancreatitis, Gallstone disease (biliary colic, cholecystitis), Diverticulitis
• Cancer of any kind
• Patients with reported history of previous resection of any part of the GI tract other than appendix or gall bladder, intestinal stoma
• Habitual use of opiate analgesics likely to alter bowel function e.g. morphine
• Use of antibiotics in the preceding two weeks and/or in the past one month
• Consumption of probiotics, prebiotics or fibre supplements in the past one month
• Enteral feeding or texture modified diet patients
• Those with cognitive impairment or severe mental disorder (Alzheimer's, schizophrenia, bipolar disorder. etc)
• Shift workers (e.g. Nurse, doctors)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Малайзия · 1 центр

• Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar — Kuala Lumpur

Публикации

• Zia JK, Lenhart A, Yang PL, Heitkemper MM, Baker J, Keefer L, Saps M, Cuff C, Hungria G, Videlock EJ, Chang L. Risk Factors for Abdominal Pain-Related Disorders of Gut-Brain Interaction in Adults and Children: A Systematic Review. Gastroenterology. 2022 Oct;163(4):995-1023.e3. doi: 10.1053/j.gastro.2022.06.028. Epub 2022 Jun 16. PMID 35716771
• Murray K, Wilkinson-Smith V, Hoad C, Costigan C, Cox E, Lam C, Marciani L, Gowland P, Spiller RC. Differential effects of FODMAPs (fermentable oligo-, di-, mono-saccharides and polyols) on small and large intestinal contents in healthy subjects shown by MRI. Am J Gastroenterol. 2014 Jan;109(1):110-9. doi: 10.1038/ajg.2013.386. Epub 2013 Nov 19. PMID 24247211
• Melchior C, Desprez C, Riachi G, Leroi AM, Dechelotte P, Achamrah N, Ducrotte P, Tavolacci MP, Gourcerol G. Anxiety and Depression Profile Is Associated With Eating Disorders in Patients With Irritable Bowel Syndrome. Front Psychiatry. 2020 Jan 8;10:928. doi: 10.3389/fpsyt.2019.00928. eCollection 2019. PMID 31969841
• MacIntosh A, Heenan PE, Wright-McNaughton M, Frampton C, Skidmore P, Wall CL, Muir J, Talley NJ, Roy NC, Gearry RB. The relationship between fermentable carbohydrates and post-prandial bowel symptoms in patients with functional bowel disorders. Front Nutr. 2023 Feb 2;10:1060928. doi: 10.3389/fnut.2023.1060928. eCollection 2023. PMID 36819701
• Jang SH, Choi SC, Kim YS, Ryu HS, Lee SY, Bahk WM. Psychological Characteristics and Quality of Life of Patients with Upper and Lower Functional Gastrointestinal Disorders. J Clin Med. 2022 Dec 23;12(1):124. doi: 10.3390/jcm12010124. PMID 36614925
• Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9. PMID 21479777
• Ghoshal UC, Gwee KA, Chen M, Gong XR, Pratap N, Hou X, Syam AF, Abdullah M, Bak YT, Choi MG, Gonlachanvit S, Chua AS, Chong KM, Siah KT, Lu CL, Xiong L, Whitehead WE. Development, Translation and Validation of Enhanced Asian Rome III Questionnaires for Diagnosis of Functional Bowel Diseases in Major Asian Languages: A Rome Foundation-Asian Neurogastroenterology and Motility Association Working Tea PMID 25537673
• Chuah KH, Beh KH, Mahamad Rappek NA, Mahadeva S. The epidemiology and quality of life of functional gastrointestinal disorders according to Rome III vs Rome IV criteria: A cross-sectional study in primary care. J Dig Dis. 2021 Mar;22(3):159-166. doi: 10.1111/1751-2980.12975. PMID 33595169

Идентификаторы

NCT: NCT07000227 · JEP-2024-1144 · FRGS/1/2023/SKK06/UKM/03/4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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