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Low FODMAP Diet on Nutritional Status, Disease Activity and Gut Microbiota in IBS and UC With Normal or Overweight BMI

NCT04143633 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2019-10-29

No results posted yet for this study

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.

Conditions

  • IBD - Inflammatory Bowel Disease
  • IBS - Irritable Bowel Syndrome
  • UC - Ulcerative Colitis

Interventions

OTHER

Low FODMAP diet

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.

OTHER

Standard diet

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.

Sponsors & Collaborators

  • Hospital General de Mexico

    lead OTHER_GOV

Principal Investigators

  • Nallely Bueno Hernádez, PhD · Hospital General de México

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-10
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04143633 on ClinicalTrials.gov