IBD - Inflammatory Bowel DiseaseNCT04143633
Low FODMAP Diet on Nutritional Status, Disease Activity and Gut Microbiota in IBS and UC With Normal or Overweight BMI
A study testing Low FODMAP diet and Standard diet in people with IBD - Inflammatory Bowel Disease and IBS - Irritable Bowel Syndrome, run by Hospital General de Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- IBD - Inflammatory Bowel Disease, IBS - Irritable Bowel Syndrome, UC - Ulcerative Colitis
- What is being tested?
- Low FODMAP diet and Standard diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteMexico
- Study dates
- 10 Feb 2018to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Karen L de León Barrera, B.S contact
Mexico1 site, 1 recruiting
- Recruiting
Nallely Bueno Hernández
Mexico City, Cuauhtémoc, 06720
Nallely Bueno Hernández, PhD, 27892000 ext. 5654, dinvestigacionhgm@gmail.com
Karen L de León Barrera, B.S., nut.karendeleon@gmail.com
About this study
Official title: Low FODMAP Diet Chronic Effect on Nutritional Status, Disease Activity and Gut Microbiota in Patients With IBS and UC
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.
Read the detailed description
Irritable Bowel Syndrome (IBS) and Ulcerative Colitis (UC) affect principally the gut, causing symptoms that alter intestinal motility, with a multifactorial etiology. The pharmacological and nutritional treatment varies according to the symptoms and activity of each patient. The most commonly used are the standard diet (SD), which excludes foods known as irritants or inflammatory. On the other hand, are the low fodmap diet (LFD) (fermentable oligosaccharides. disaccharides, monosaccharides and polyols), these highly fermentable carbohydrates can pass unabsorbed to the colon and induce the gas production due to the fermentation of gut microbiota and cause symptoms such as: bloating, flatulence, abdominal pain and altered bowel habit. It consists in two stages: first the restriction of all foods that contain fodmaps and second the re exposure in which indicate the introduction of each food restricted before to evaluate the tolerance, for 6 to 8 weeks. Some studies show that the low fodmap diet improve the symptoms in both groups, however because of the restriction and the limited content of foods, they have had risk to present nutritional deficiencies. The aim of the present is to evaluate the effect of a low fodmap diet for 10 weeks on gastrointestinal symptoms, nutritional status and microbiota in patients with IBS and UC.
Methods: a controlled, blinded clinical trial will be conducted in patients who assist to medical monitoring in gastroenterology service with diagnosis of IBS or UC. The sample size was determined with a 0.5 effect size, an alpha error 0.05 and power of 80%, which determined 64 patients for each group (total: 128). After singing the informed consent, will be determined their total energy expenditure (TEE) and consecutively will be assigned an ID previously randomized to SD (<16 g of fodmaps) or LFD (<10 g of fodmaps), with a distribution of 55% carbohydrates, 20% proteins and 25% lipids. During the 10 weeks will be three follow-ups, first the basal, intermediate (week 5) and final (10 weeks after), will be performed body composition (RJL Quantum III), anthropometry (waist, hip, arm and chest circumference), gastrointestinal symptoms (ROMA III and Mayo Scale), quality of life (WHOQL-BREF), food frequency and 24-hour reminder and blood chemistry (anemia, hypoalbuminemia, vitamin D, calcium, potassium, c reactive protein, VSG, etc), all of them basal and final.
- Being tested
- Low FODMAP diet, Standard diet
- Keywords
- Irritable Bowel Syndrome, Ulcerative Colitis, Low FODMAP diet, Nutritional status, Standard diet
- Medical subject headings
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low FODMAP dietOther
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.
Standard dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| FODMAP diet in Irritable Bowel Syndrome | Experimental | Patients 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. Receives: Other: Low FODMAP diet; Other: Standard diet |
| FODMAP diet in Ulcerative Colitis | Experimental | Patients 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. Receives: Other: Low FODMAP diet; Other: Standard diet |
| FODMAP diet in healthy patients | Active comparator | Healthy 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. Receives: Other: Low FODMAP diet; Other: Standard diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Changes from baseline of WHOQOL- BREF (World Health Organization Quality of Life) questionary score (the higher score, the higher quality of life represents) measured with a Likert scale at 10 weeks of nutritional intervention in patients wiht irritable bowel syndrome and inflammatory bowel disease
Measured: The patients will be evaluated at weeks 1, 5 and 10
Adherence to treatment
By 24 hour recalls during the ten weeks of the study and food frequencies at week one, five and ten.
Measured: The patients will be evaluated at weeks 1, 5 and 10
Body composition analysis
Changes from baseline of the percentage of body fat (%), muscle (%) and water (%) at 10 weeks of nutritional intervention, using RJL System IV
Measured: The patients will be evaluated at weeks 1, 5 and 10
Gut microbiota with a low FODMAP diet
The patient will be asked for a stool sample before and after the diet, the microbiota were measure by PCR
Measured: Participants will be evaluated at weeks 1, 5 and 10
Blood chemistry
Changes from baseline glucose, creatinine, high density lipoproteins, low density lipoproteins, cholesterol levels (mg/dL) at 10 weeks of nutritional intervention in patients with IBS and IBD
Measured: Participants will be evaluated at weeks 1 and 10
Irritable Bowel Syndrome Severity Score
Changes from baseline in the presence or absence of gastrointestinal symptoms where the higher the score, more severity of symptoms are assesed using a percentage scale 0-100%, at 10 weeks with low FODMAP diet in patients wih IBS and IBD
Measured: Participants will be evaluated at weeks 1, 5 and 10
Gastrointestinal Symptoms Severity
Changes from baseline of presence or abscense of gastrointestinal symptoms where the higher the score, the higher severity of symptoms (assesed using cualitative scale with options ranging from minimal symptoms to very annoying symptoms) at 10 weeks with low FODMAP diet in patients wih IBS and IBD
Measured: Participants will be evaluated at weeks 1, 5 and 10
Anthropometric measurements
Changes from baseline of arm, waist and hips circumferences in centimeters at 12 weeks of nutritional intervention in patientes with IBS anda IBD
Measured: Participants will be evaluated at weeks 1, 5 and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start10 Feb 2018
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD - Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nallely Bueno Hernández, Hospital General de Mexico
- Investigators
- Nallely Bueno Hernádez, PhD, Principal investigator, Hospital General de México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143633
- Sponsor's protocol ID
- DI/17/301/03/084
- Status last verified
- Mar 2019
- First submitted
- 8 Oct 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low FODMAP Diet Chronic Effect on Nutritional Status, Disease Activity and Gut Microbiota in Patients With IBS and UC
- ClinicalTrials.gov ID
- NCT04143633
- Acronym / sponsor ID
- DI/17/301/03/084
- Keywords
- Irritable Bowel Syndrome, Ulcerative Colitis, Low FODMAP diet, Nutritional status, Standard diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Hospital General de MexicoOther government
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Irritable Bowel Syndrome (IBS) and Ulcerative Colitis (UC) affect principally the gut, causing symptoms that alter intestinal motility, with a multifactorial etiology. The pharmacological and nutritional treatment varies according to the symptoms and activity of each patient. The most commonly used are the standard diet (SD), which excludes foods known as irritants or inflammatory. On the other hand, are the low fodmap diet (LFD) (fermentable oligosaccharides. disaccharides, monosaccharides and polyols), these highly fermentable carbohydrates can pass unabsorbed to the colon and induce the gas production due to the fermentation of gut microbiota and cause symptoms such as: bloating, flatulence, abdominal pain and altered bowel habit. It consists in two stages: first the restriction of all foods that contain fodmaps and second the re exposure in which indicate the introduction of each food restricted before to evaluate the tolerance, for 6 to 8 weeks. Some studies show that the low fodmap diet improve the symptoms in both groups, however because of the restriction and the limited content of foods, they have had risk to present nutritional deficiencies. The aim of the present is to evaluate the effect of a low fodmap diet for 10 weeks on gastrointestinal symptoms, nutritional status and microbiota in patients with IBS and UC.
Methods: a controlled, blinded clinical trial will be conducted in patients who assist to medical monitoring in gastroenterology service with diagnosis of IBS or UC. The sample size was determined with a 0.5 effect size, an alpha error 0.05 and power of 80%, which determined 64 patients for each group (total: 128). After singing the informed consent, will be determined their total energy expenditure (TEE) and consecutively will be assigned an ID previously randomized to SD (<16 g of fodmaps) or LFD (<10 g of fodmaps), with a distribution of 55% carbohydrates, 20% proteins and 25% lipids. During the 10 weeks will be three follow-ups, first the basal, intermediate (week 5) and final (10 weeks after), will be performed body composition (RJL Quantum III), anthropometry (waist, hip, arm and chest circumference), gastrointestinal symptoms (ROMA III and Mayo Scale), quality of life (WHOQL-BREF), food frequency and 24-hour reminder and blood chemistry (anemia, hypoalbuminemia, vitamin D, calcium, potassium, c reactive protein, VSG, etc), all of them basal and final.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FODMAP diet in Irritable Bowel Syndrome | Experimental | Other: Low FODMAP diet, Other: Standard dietPatients 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 | Experimental | Other: Low FODMAP diet, Other: Standard dietPatients 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 comparator | Other: Low FODMAP diet, Other: Standard dietHealthy 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Chron´s disease diagnosed
- Treatment whith antibiotis during the last two weeks
- Bowel resection
- Short bowel syndrome
- Treatment wihth probiotics or enzimes (A-galactosidase)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low FODMAP dietThe 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 | FODMAP diet in Irritable Bowel Syndrome, FODMAP diet in Ulcerative Colitis, FODMAP diet in healthy patients |
| Standard dietThe 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. | Other | FODMAP diet in Irritable Bowel Syndrome, FODMAP diet in Ulcerative Colitis, FODMAP diet in healthy patients |
Primary outcome
Nutritional status
Time frame: The patients will be evaluated at weeks 1 and 10
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
8 secondary outcomes
Quality of life in patients with Irritable Bowel Syndrome and Inflammatory Bowel Disease
Time frame: The patients will be evaluated at weeks 1, 5 and 10
Adherence to treatment
Time frame: The patients will be evaluated at weeks 1, 5 and 10
Body composition analysis
Time frame: The patients will be evaluated at weeks 1, 5 and 10
Gut microbiota with a low FODMAP diet
Time frame: Participants will be evaluated at weeks 1, 5 and 10
Blood chemistry
Time frame: Participants will be evaluated at weeks 1 and 10
Irritable Bowel Syndrome Severity Score
Time frame: Participants will be evaluated at weeks 1, 5 and 10
Gastrointestinal Symptoms Severity
Time frame: Participants will be evaluated at weeks 1, 5 and 10
Anthropometric measurements
Time frame: Participants will be evaluated at weeks 1, 5 and 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen L de León Barrera, B.S contact
Nallely Bueno Hernádez, PhD principal investigator
Hospital General de México
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low FODMAP diet and Standard diet in people with IBD - Inflammatory Bowel Disease and IBS - Irritable Bowel Syndrome, run by Hospital General de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nallely Bueno Hernández, PhD (27892000 ext. 5654, nallely_bh5@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional status (time frame: The patients will be evaluated at weeks 1 and 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.