- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02902926
Comparison of Microbiota and Quality of Life for a Low FODMAPs and Standard Dietary in Irritable Bowel Syndrome Patients
Comparison of Microbiota and Quality of Life for a Low FODMAPs Versus Standard Dietary Advice in Patients With Irritable Bowel Syndrome
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
IBS is a global disease, patients often because of long-term symptoms of recurrent, not timely diagnosis and treatment effect is not ideal and frequent treatment, seriously affect the quality of life, and cause the corresponding economic and social burden.At present,a number of studies suggest that fermentable oligosaccharides, disaccharides and monosaccharides and polyols (FODMAPs) can induce IBS symptoms.Data from large randomized controlled trials are limited, leaving clinicians with the challenge of providing patients with reliable guidance based on minimal evidence.
This study will compare the effect of low FODMAPs diet and usual diet instruction on Intestinal flora, intestinal short chain fatty acids and quality of life by two groups.The results will answer the effect and long-term safety of Low FODMAPs diet.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Tianqi Zhou, Dr.
- Numéro de téléphone: +8618852727248
- E-mail: 651299080@qq.com
Sauvegarde des contacts de l'étude
- Nom: Yamei Gu, Dr.
- Numéro de téléphone: 15252573426
- E-mail: 286508374@qq.com
Lieux d'étude
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Jiangsu
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Yangzhou, Jiangsu, Chine, 225001
- Recrutement
- YangzhouUniversity
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Contact:
- Tianqi Zhou, Dr.
- Numéro de téléphone: +8618852727248
- E-mail: 651299080@qq.com
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Contact:
- Yamei Gu, Dr.
- Numéro de téléphone: +8615252573426
- E-mail: 286508374@qq.com
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Chercheur principal:
- Jinsong Wang, Ph.D.,M.D.
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Diagnostic criteria for Rome Ⅲ
- IBS patients with diarrhea type
- By endoscopy, X-ray, B ultrasound and laboratory examination to exclude organic disease
- Patients be able to communicate well with the researchers and be willing to participate in the study
Exclusion Criteria:
- Stomach, small intestine, colon surgery history
- irritable bowel disease (IBD) active period, celiac disease
- Alcoholics or drug abuse
- Pregnant or lactating women
- Recent drug users who use defecation
- Have a special diet
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Low FODMAPs Diet
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Instruct to design and eat Low Fermentable,Oligo-,Di-,Mono-saccharides And Polyols(FODMAPs) Diet
Answer the doubt and help the patient get the diet knowlege about the IBS.
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Comparateur placebo: Diet Instruction
1.Answer doubts and correct unhealthy dietary behaviors,such as excessive diet, eating raw, spirits and other excitant food.
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Answer the doubt and help the patient get the diet knowlege about the IBS.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Microbiota / Short chain fatty acids
Délai: Change from baseline Microbiota / Short chain fatty acids at 4 weeks
|
The fecal samples of IBS patients were analyzed.
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Change from baseline Microbiota / Short chain fatty acids at 4 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Irritable bowel syndrome severity scoring system scale
Délai: Baseline,1,and 3 month post randomization
|
Irritable bowel syndrome severity scoring system scale is an integral system for monitoring the severity of IBS in patients with disease severity.The scale is mainly from the degree of abdominal pain, abdominal pain frequency, abdominal distension, defecation satisfaction and the impact of life, according to the 10cm visual scoring method
|
Baseline,1,and 3 month post randomization
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The Short Form 36 (SF-36) scale
Délai: Baseline,1,and 3 month post randomization
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SF-36 is a general scale, at present, the most commonly used evaluation of IBS.
It includes 36 items, a total of 8 dimensions
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Baseline,1,and 3 month post randomization
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Irritable bowel syndrome quality of life (IBS-QOL) scale
Délai: Baseline,1,and 3 month post randomization
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Irritable bowel syndrome quality of life (IBS-QOL) scale is a more extensive application of the specific scale of IBS.
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Baseline,1,and 3 month post randomization
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Satisfaction questionnaire
Délai: 1,and 3 month post randomization
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To understand the patient's satisfaction with symptom control and diet guidance.
The questionnaire included 3 items
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1,and 3 month post randomization
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Hongcan Shi, Ph.D.,M.D., Medical College
Publications et liens utiles
Publications générales
- Canavan C, West J, Card T. Review article: the economic impact of the irritable bowel syndrome. Aliment Pharmacol Ther. 2014 Nov;40(9):1023-34. doi: 10.1111/apt.12938. Epub 2014 Sep 9.
- Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):712-721.e4. doi: 10.1016/j.cgh.2012.02.029. Epub 2012 Mar 15.
- Eswaran S, Tack J, Chey WD. Food: the forgotten factor in the irritable bowel syndrome. Gastroenterol Clin North Am. 2011 Mar;40(1):141-62. doi: 10.1016/j.gtc.2010.12.012.
- Bohn L, Storsrud S, Tornblom H, Bengtsson U, Simren M. Self-reported food-related gastrointestinal symptoms in IBS are common and associated with more severe symptoms and reduced quality of life. Am J Gastroenterol. 2013 May;108(5):634-41. doi: 10.1038/ajg.2013.105.
- Iacovou M, Tan V, Muir JG, Gibson PR. The Low FODMAP Diet and Its Application in East and Southeast Asia. J Neurogastroenterol Motil. 2015 Oct 1;21(4):459-70. doi: 10.5056/jnm15111.
- De Giorgio R, Volta U, Gibson PR. Sensitivity to wheat, gluten and FODMAPs in IBS: facts or fiction? Gut. 2016 Jan;65(1):169-78. doi: 10.1136/gutjnl-2015-309757. Epub 2015 Jun 15.
- Gibson PR, Varney J, Malakar S, Muir JG. Food components and irritable bowel syndrome. Gastroenterology. 2015 May;148(6):1158-74.e4. doi: 10.1053/j.gastro.2015.02.005. Epub 2015 Feb 11.
- Hyland NP, Quigley EM, Brint E. Microbiota-host interactions in irritable bowel syndrome: epithelial barrier, immune regulation and brain-gut interactions. World J Gastroenterol. 2014 Jul 21;20(27):8859-66. doi: 10.3748/wjg.v20.i27.8859.
- Jain I, Kumar V, Satyanarayana T. Xylooligosaccharides: an economical prebiotic from agroresidues and their health benefits. Indian J Exp Biol. 2015 Mar;53(3):131-42.
- Halmos EP, Power VA, Shepherd SJ, Gibson PR, Muir JG. A diet low in FODMAPs reduces symptoms of irritable bowel syndrome. Gastroenterology. 2014 Jan;146(1):67-75.e5. doi: 10.1053/j.gastro.2013.09.046. Epub 2013 Sep 25.
- Bohn L, Storsrud S, Liljebo T, Collin L, Lindfors P, Tornblom H, Simren M. Diet low in FODMAPs reduces symptoms of irritable bowel syndrome as well as traditional dietary advice: a randomized controlled trial. Gastroenterology. 2015 Nov;149(6):1399-1407.e2. doi: 10.1053/j.gastro.2015.07.054. Epub 2015 Aug 5.
- Whigham L, Joyce T, Harper G, Irving PM, Staudacher HM, Whelan K, Lomer MC. Clinical effectiveness and economic costs of group versus one-to-one education for short-chain fermentable carbohydrate restriction (low FODMAP diet) in the management of irritable bowel syndrome. J Hum Nutr Diet. 2015 Dec;28(6):687-96. doi: 10.1111/jhn.12318. Epub 2015 Apr 14.
- Marsh A, Eslick EM, Eslick GD. Does a diet low in FODMAPs reduce symptoms associated with functional gastrointestinal disorders? A comprehensive systematic review and meta-analysis. Eur J Nutr. 2016 Apr;55(3):897-906. doi: 10.1007/s00394-015-0922-1. Epub 2015 May 17.
- Chumpitazi BP, Cope JL, Hollister EB, Tsai CM, McMeans AR, Luna RA, Versalovic J, Shulman RJ. Randomised clinical trial: gut microbiome biomarkers are associated with clinical response to a low FODMAP diet in children with the irritable bowel syndrome. Aliment Pharmacol Ther. 2015 Aug;42(4):418-27. doi: 10.1111/apt.13286. Epub 2015 Jun 24.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20160805
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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