Efficacy of a Low FODMAP Diet in the Absence of Lactose Malabsorption in Moderate to Severe ROME IV IBS.
Primary Purpose
Irritable Bowel Syndrome
Status
Recruiting
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
FODMAP diet
Sponsored by
About this trial
This is an interventional diagnostic trial for Irritable Bowel Syndrome
Eligibility Criteria
Inclusion Criteria:
- - Patients aged 18 - 75 years;
- Fulfilling the ROME IV criteria for IBS;
- Moderate symptom severity as defined by a IBS-SSS > 175;
- Consumption of lactose containing products.
Exclusion Criteria:
- - Clinical suspicion of an organic disorder different from LI or IBS (patients can be included when this disorder had been excluded);
- Known lactose intolerance;
- Known inflammatory bowel disorder;
- Known major intestinal motility disorder;
- Alcohol (defined as more than 14 U per week) or other substance abuse;
- Active psychiatric disorder;
- Known systemic or auto-immune disorder with implication for the GI system;
- Prior abdominal surgery (with the exception of appendectomy);
- Any prior diagnosis of cancer other than basocellular carcinoma;
- Current chemotherapy;
- History of gastro-enteritis in the past 8 weeks;
- Intake of antibiotics, pre- or probiotics during the past 8 weeks;
- Dietary supplements unless taken at a stable dose for more than 8 weeks;
- Treatment with neuromodulators (one neuromodulator taken at a stable dose for more than 12 weeks is allowed);
- Treatment with spasmolytic agents, opioids, loperamide, gelatin tannate or mucoprotectants during the past 8 weeks;
- LFD or low FODMAP diet in the past.
Sites / Locations
- UZ BrusselRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FODMAP diet
Arm Description
Outcomes
Primary Outcome Measures
symptomatic improvement
To evaluate the symptomatic improvement by a low FODMAP diet in Rome IV IBS patients with-out documented lactose malabsorption.
Evolution of Quality of life scale
Evolution of quality of life by the low FODMAP diet.
Secondary Outcome Measures
reduction in Irritable bowel syndrome - symptom severity scale
Reduction of IBS-SSS at 4 weeks of diet vs. baseline depending on the reduction of FOD-MAP consumption;
Full Information
NCT ID
NCT05120752
First Posted
July 13, 2021
Last Updated
August 3, 2022
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT05120752
Brief Title
Efficacy of a Low FODMAP Diet in the Absence of Lactose Malabsorption in Moderate to Severe ROME IV IBS.
Official Title
Efficacy of a Low FODMAP Diet in the Absence of Lactose Malabsorption in Moderate to Severe ROME IV IBS.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Irritable bowel syndrome (IBS) is a frequently encountered disorder. According to the Rome IV criteria, it is characterized by abdominal pain associated with a change in stool frequency or con-sistency, or with symptomatic improvement by defecation (Mearin 2016). Associated symptoms, such as bloating and flatulence, are frequently reported. The underlying pathophysiology remains obscure, although several pathways have been proposed. Low-grade immune activation, visceral hypersensitivity, alteration in gut microbiome have all been reported (Mearin 2016). As diet exerts an impact on all these pathophysiological mechanisms, the role of dietary intervention receives spe-cial attention, with special interest in the role played by so-called fermentable oligo-, di-, monosac-charides and polyols (FODMAPs). Multiple studies indicated the beneficial effects of the low FODMAP diet in at least part of the patients (Halmos 2014, Eswaran 2016, Staudacher 2017).
As a disaccharide, lactose is part of the FODMAPs. Lactose intolerance (LI) results from lactose malabsorption (LM) secondary to insufficient hydrolysis of the disaccharide lactose into galactose and glucose (Misselwitz 2019). The undigested lactose will eventually reach the colon, resulting in fermentation from colonic bacteria with production of different compounds such as short chain fat-ty acids, carbon dioxide, H2 and methane (Catanzaro 2021). These compounds have an osmotic effect and can stimulate colonic contractions. In patients suffering from LI, these pathophysiologi-cal mechanisms generate symptoms such as abdominal pain and cramps, flatulence, diarrhea, in-creased bowel sounds, among others, similar to the mechanisms by which FODMAPs induce symp-toms of IBS. As dairy products are highly present in our Western diet, LI will often be considered in patients presenting with such symptoms and they will be referred for further testing. When LM is diagnosed, a lactose-free diet (LFD) will be advocated to alleviate symptoms.
While the earlier-mentioned studies investigated symptomatic improvement by the low FODMAP diet, it remains uncertain whether this restrictive diet remains beneficial in patients without evidence of LM. In a recent study the low FODMAP diet and LFD provided comparable improvement in symptom severity (Krieger-Grübel 2020).
This study aims to:
Assess the improvement in IBS symptoms and quality of life (QOL) by a low FODMAP di-et when lactose malabsorption has been previously excluded;
Compare the improvement in IBS symptoms and QOL obtained by a low FODMAP diet to a lactose free diet (data from the PreVaIL study).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FODMAP diet
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
FODMAP diet
Intervention Description
all participants need to follow a low FODMAP diet, the information will be given by a trained dietitian
Primary Outcome Measure Information:
Title
symptomatic improvement
Description
To evaluate the symptomatic improvement by a low FODMAP diet in Rome IV IBS patients with-out documented lactose malabsorption.
Time Frame
3 to 4 months
Title
Evolution of Quality of life scale
Description
Evolution of quality of life by the low FODMAP diet.
Time Frame
3 to 4 months
Secondary Outcome Measure Information:
Title
reduction in Irritable bowel syndrome - symptom severity scale
Description
Reduction of IBS-SSS at 4 weeks of diet vs. baseline depending on the reduction of FOD-MAP consumption;
Time Frame
baseline till week 4, baseline till week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18 - 75 years;
Fulfilling the ROME IV criteria for IBS;
Moderate symptom severity as defined by a IBS-SSS > 175;
Consumption of lactose containing products.
Exclusion Criteria:
- Clinical suspicion of an organic disorder different from LI or IBS (patients can be included when this disorder had been excluded);
Known lactose intolerance;
Known inflammatory bowel disorder;
Known major intestinal motility disorder;
Alcohol (defined as more than 14 U per week) or other substance abuse;
Active psychiatric disorder;
Known systemic or auto-immune disorder with implication for the GI system;
Prior abdominal surgery (with the exception of appendectomy);
Any prior diagnosis of cancer other than basocellular carcinoma;
Current chemotherapy;
History of gastro-enteritis in the past 8 weeks;
Intake of antibiotics, pre- or probiotics during the past 8 weeks;
Dietary supplements unless taken at a stable dose for more than 8 weeks;
Treatment with neuromodulators (one neuromodulator taken at a stable dose for more than 12 weeks is allowed);
Treatment with spasmolytic agents, opioids, loperamide, gelatin tannate or mucoprotectants during the past 8 weeks;
LFD or low FODMAP diet in the past.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sébastien Kindt, MD
Phone
+32 2 476
Ext
37 15
Email
sebastien.kindt@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien Kindt, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Brussel
City
Jette
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien Kindt, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of a Low FODMAP Diet in the Absence of Lactose Malabsorption in Moderate to Severe ROME IV IBS.
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