Low FODMAP Diet on Nutritional Status, Disease Activity and Gut Microbiota in IBS and UC With Normal or Overweight BMI
Low FODMAP Diet Chronic Effect on Nutritional Status, Disease Activity and Gut Microbiota in Patients With IBS and UC
1 other identifier
interventional
105
1 country
1
Brief Summary
Gastrointestinal disorders represents 20-50% of referrals to the gastroenterologist; being the most affected womens, youths and older adults. Among these alterations are the Irritable Bowel Syndrome (IBS) and Ulcerative Colitis (UC), which affects the gut causing impaired motility. The pharmacological and nutritional treatment are modified according to the symptomatology and activity of each patients. Currently the implementation of low FODMAP diets for 6 to 8 weeks in patients whith IBS improves symptoms such as bloating, flatulence and abdominal pain. However due to the number of restricted foods a long term attachment could limited the nutritional content, consequently affecting the nutritional status, gut microbiota an quality of life. A low FODMAP diet are useful to improve gastrointestinal symptoms in patients with UC and causes changes in nutritional status.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 10, 2018
CompletedFirst Submitted
Initial submission to the registry
October 8, 2019
CompletedFirst Posted
Study publicly available on registry
October 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedOctober 29, 2019
March 1, 2019
2.6 years
October 8, 2019
October 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nutritional status
Changes from baseline of nutrtitional status measured with cholesterol (mg/dl), triglycerides (mg/dl), albumin (mg/dl), calcium (mg/dl), iron (mg/dl), vitamin B12 (mg/dl), vitamin D (mg/dl), hemoglobin (mg/dl), hematocrit (mg/dl), creatinin (mg/dl) on blood
The patients will be evaluated at weeks 1 and 10
Secondary Outcomes (8)
Quality of life in patients with Irritable Bowel Syndrome and Inflammatory Bowel Disease
The patients will be evaluated at weeks 1, 5 and 10
Adherence to treatment
The patients will be evaluated at weeks 1, 5 and 10
Body composition analysis
The patients will be evaluated at weeks 1, 5 and 10
Gut microbiota with a low FODMAP diet
Participants will be evaluated at weeks 1, 5 and 10
Blood chemistry
Participants will be evaluated at weeks 1 and 10
- +3 more secondary outcomes
Study Arms (3)
FODMAP diet in Irritable Bowel Syndrome
EXPERIMENTALPatients with IBS will be randomized to standard diet or low fodmap diet. The nutritional status (body composition and clinical parameters), gut microbiota, adherence to treatment, improvement of gastrointestinal symptoms and quality of life will be evaluated for 10 weeks.
FODMAP diet in Ulcerative Colitis
EXPERIMENTALPatients with UC will be randomized to standard diet or low fodmap diet. The nutritional status (body composition and clinical parameters), gut microbiota, adherence to treatment, improvement of gastrointestinal symptoms and quality of life will be evaluated for 10 weeks.
FODMAP diet in healthy patients
ACTIVE COMPARATORHealthy patients will be randomized to standard diet or low fodmap diet. The nutritional status (body composition and clinical parameters), gut microbiota, adherence to treatment, improvement of gastrointestinal symptoms and quality of life will be evaluated for 10 weeks.
Interventions
The diet will be in accordance to the baseline energy expenditure calculated by Harris-Benedict whit 55% of carbohydrates, 25% of lipids and 20% of proteins, divided in five meals. The distribution of carbohydrates depends on the content of fodmaps on each food.
The diet will be in accordance to the baseline energy expenditure calculated by Harris-Benedict whit 55% of carbohydrates, 25% of lipids and 20% of proteins, divided in five meals. Cruciferous vegetables, fruits and condiments will be eliminated and a normal content of fodmap.
Eligibility Criteria
You may qualify if:
- Irritable Bowel Syndrome confirmed by Rome criteria III
- Ulcerative Colitis confirmed by Mayo Scale
- Informed Consent signed
- BMI between 18.5 and 29.9 kg/m2
- Males and females
- Age between 18-59 years
- Mexican patients
You may not qualify if:
- Chron´s disease diagnosed
- Treatment whith antibiotis during the last two weeks
- Bowel resection
- Short bowel syndrome
- Treatment wihth probiotics or enzimes (A-galactosidase)
- Pregnancy
- Nutritional deficiencies or anemia
- Patients whith diet supplements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nallely Bueno Hernández
Mexico City, Cuauhtémoc, 06720, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nallely Bueno Hernádez, PhD
Hospital General de México
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The patient doesn´t know the type of diet (standard or low FODMAP)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator In Medical Science B
Study Record Dates
First Submitted
October 8, 2019
First Posted
October 29, 2019
Study Start
February 10, 2018
Primary Completion
August 31, 2020
Study Completion
August 31, 2020
Last Updated
October 29, 2019
Record last verified: 2019-03