Low FODMAP Diet in FD (PDS)

NCT05832528 | Recruiting

• 1 other identifier: S66225
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this dietary intervention study is to assess the efficacy and mechanisms of a low-FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diet in functional dyspepsia patients. The main questions it aims to answer are:

• If a low-FODMAP diet can reduce dyspeptic complaints
• How a low-FODMAP diet can reduce dyspeptic complaints in functional dyspepsia (FD). Participants will follow a 6-week during low-FODMAP diet followed by powder reintroduction of 6 FODMAPs and 1 control substance.

Conditions

Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (1)

• Effect of a low-FODMAP diet on the LPDS (Leuven-postprandial distress scale)

  Validated Leuven-postprandial distress scale for dyspeptic symptoms (0-15, higher scores indicating more severe symptoms)

  Measurement before and after the diet (6 weeks)

Secondary Outcomes (3)

• Effect of a low-FODMAP diet on urinary histamine and N-methylhistamine excretion

  Measurement before and after the diet (6 weeks)

• Effect of a low-FODMAP diet on duodenal mucosal integrity

  Measurement before and after the diet (6 weeks)

• Effect of a low-FODMAP diet on duodenal low-grade inflammation

  Measurement before and after the diet (6 weeks)

Study Arms (1)

FD patient

EXPERIMENTAL

Low-FODMAP diet in patients with FD for 6 weeks.

Other: Low-FODMAP diet

Interventions

Low-FODMAP diet OTHER

6-week Low-FODMAP diet in patients with functional dyspepsia

FD patient

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Functional dyspepsia/ postprandial distress syndrome as per Rome IV diagnostic criteria
• Symptom characteristics of dyspepsia (upper gastrointestinal symptoms occurring in the last 6 months and meal related (PDS))
• Negative endoscopy (maximum 12 months old)
• Patients must provide witnessed written informed consent prior to any study procedures being performed
• Patients aged between 18 and 70 years inclusive
• Male or female patients

You may not qualify if:

• Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
• Patients with any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years
• Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) and of gastro-oesophageal reflux disease (GERD)
• Patients who changed their diet over the last 3 months or have previously tried the low FODMAP diet are excluded from the study.
• Females who are pregnant or lactating are excluded from the study.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Related Publications (19)

• Tack J, Talley NJ, Camilleri M, Holtmann G, Hu P, Malagelada JR, Stanghellini V. Functional gastroduodenal disorders. Gastroenterology. 2006 Apr;130(5):1466-79. doi: 10.1053/j.gastro.2005.11.059.

  PMID: 16678560 BACKGROUND

• Lacy BE, Weiser KT, Kennedy AT, Crowell MD, Talley NJ. Functional dyspepsia: the economic impact to patients. Aliment Pharmacol Ther. 2013 Jul;38(2):170-7. doi: 10.1111/apt.12355. Epub 2013 Jun 3.

  PMID: 23725230 BACKGROUND

• Piessevaux H, De Winter B, Louis E, Muls V, De Looze D, Pelckmans P, Deltenre M, Urbain D, Tack J. Dyspeptic symptoms in the general population: a factor and cluster analysis of symptom groupings. Neurogastroenterol Motil. 2009 Apr;21(4):378-88. doi: 10.1111/j.1365-2982.2009.01262.x. Epub 2009 Feb 12.

  PMID: 19222761 BACKGROUND

• Talley NJ, Verlinden M, Jones M. Validity of a new quality of life scale for functional dyspepsia: a United States multicenter trial of the Nepean Dyspepsia Index. Am J Gastroenterol. 1999 Sep;94(9):2390-7. doi: 10.1111/j.1572-0241.1999.01363.x.

  PMID: 10483997 BACKGROUND

• El-Serag HB, Talley NJ. Health-related quality of life in functional dyspepsia. Aliment Pharmacol Ther. 2003 Aug 15;18(4):387-93. doi: 10.1046/j.1365-2036.2003.01706.x.

  PMID: 12940923 BACKGROUND

• Jones MP, Talley NJ, Eslick GD, Dubois D, Tack J. Community subgroups in dyspepsia and their association with weight loss. Am J Gastroenterol. 2008 Aug;103(8):2051-60. doi: 10.1111/j.1572-0241.2008.01935.x.

  PMID: 18796099 BACKGROUND

• Aro P, Talley NJ, Agreus L, Johansson SE, Bolling-Sternevald E, Storskrubb T, Ronkainen J. Functional dyspepsia impairs quality of life in the adult population. Aliment Pharmacol Ther. 2011 Jun;33(11):1215-24. doi: 10.1111/j.1365-2036.2011.04640.x. Epub 2011 Mar 28.

  PMID: 21443537 BACKGROUND

• Tack J, Piessevaux H, Coulie B, Caenepeel P, Janssens J. Role of impaired gastric accommodation to a meal in functional dyspepsia. Gastroenterology. 1998 Dec;115(6):1346-52. doi: 10.1016/s0016-5085(98)70012-5.

  PMID: 9834261 BACKGROUND

• Carbone F, Tack J, Hoffman I. The Intragastric Pressure Measurement: A Novel Method to Assess Gastric Accommodation in Functional Dyspepsia Children. J Pediatr Gastroenterol Nutr. 2017 Jun;64(6):918-924. doi: 10.1097/MPG.0000000000001386.

  PMID: 27557427 BACKGROUND

• Janssen P, Verschueren S, Ly HG, Vos R, Van Oudenhove L, Tack J. Intragastric pressure during food intake: a physiological and minimally invasive method to assess gastric accommodation. Neurogastroenterol Motil. 2011 Apr;23(4):316-22, e153-4. doi: 10.1111/j.1365-2982.2011.01676.x. Epub 2011 Feb 7.

  PMID: 21299720 BACKGROUND

• Lee KJ, Tack J. Duodenal implications in the pathophysiology of functional dyspepsia. J Neurogastroenterol Motil. 2010 Jul;16(3):251-7. doi: 10.5056/jnm.2010.16.3.251. Epub 2010 Jul 26.

  PMID: 20680163 BACKGROUND

• Farre R, Tack J. Food and symptom generation in functional gastrointestinal disorders: physiological aspects. Am J Gastroenterol. 2013 May;108(5):698-706. doi: 10.1038/ajg.2013.24. Epub 2013 Mar 5.

  PMID: 23458851 BACKGROUND

• Vanheel H, Vicario M, Vanuytsel T, Van Oudenhove L, Martinez C, Keita AV, Pardon N, Santos J, Soderholm JD, Tack J, Farre R. Impaired duodenal mucosal integrity and low-grade inflammation in functional dyspepsia. Gut. 2014 Feb;63(2):262-71. doi: 10.1136/gutjnl-2012-303857. Epub 2013 Mar 8.

  PMID: 23474421 BACKGROUND

• Belic A, Grabnar I, Karba R, Mrhar A, Irman-Florjanc T, Primozic S. Interdependence of histamine and methylhistamine kinetics: modelling and simulation approach. Comput Biol Med. 1999 Nov;29(6):361-75. doi: 10.1016/s0010-4825(99)00017-7.

  PMID: 10591171 BACKGROUND

• Walker MM, Aggarwal KR, Shim LS, Bassan M, Kalantar JS, Weltman MD, Jones M, Powell N, Talley NJ. Duodenal eosinophilia and early satiety in functional dyspepsia: confirmation of a positive association in an Australian cohort. J Gastroenterol Hepatol. 2014 Mar;29(3):474-9. doi: 10.1111/jgh.12419.

  PMID: 24304041 BACKGROUND

• Talley NJ, Walker MM, Aro P, Ronkainen J, Storskrubb T, Hindley LA, Harmsen WS, Zinsmeister AR, Agreus L. Non-ulcer dyspepsia and duodenal eosinophilia: an adult endoscopic population-based case-control study. Clin Gastroenterol Hepatol. 2007 Oct;5(10):1175-83. doi: 10.1016/j.cgh.2007.05.015. Epub 2007 Aug 7.

  PMID: 17686660 BACKGROUND

• Vanuytsel T, van Wanrooy S, Vanheel H, Vanormelingen C, Verschueren S, Houben E, Salim Rasoel S, Tomicronth J, Holvoet L, Farre R, Van Oudenhove L, Boeckxstaens G, Verbeke K, Tack J. Psychological stress and corticotropin-releasing hormone increase intestinal permeability in humans by a mast cell-dependent mechanism. Gut. 2014 Aug;63(8):1293-9. doi: 10.1136/gutjnl-2013-305690. Epub 2013 Oct 23.

  PMID: 24153250 BACKGROUND

• Raithel M, Hagel A, Albrecht H, Zopf Y, Naegel A, Baenkler HW, Buchwald F, Schultis HW, Kressel J, Hahn EG, Konturek P. Excretion of urinary histamine and N-tele methylhistamine in patients with gastrointestinal food allergy compared to non-allergic controls during an unrestricted diet and a hypoallergenic diet. BMC Gastroenterol. 2015 Apr 1;15:41. doi: 10.1186/s12876-015-0268-4.

  PMID: 25888445 BACKGROUND

• Carbone F, Vandenberghe A, Holvoet L, Vanuytsel T, Van Oudenhove L, Jones M, Tack J. Validation of the Leuven Postprandial Distress Scale, a questionnaire for symptom assessment in the functional dyspepsia/postprandial distress syndrome. Aliment Pharmacol Ther. 2016 Nov;44(9):989-1001. doi: 10.1111/apt.13753. Epub 2016 Aug 12.

  PMID: 27518319 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Dietary intervention trial

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: April 27, 2023
• Study Start: October 3, 2022
• Primary Completion: January 1, 2025
• Study Completion: February 15, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

BE (1)