Irritable Bowel SyndromeNCT01339117
Delivered Dietary Intervention for Children With Irritable Bowel Syndrome
A study testing Low fermentable substrate diet and High fermentable substrate diet in people with Irritable Bowel Syndrome and Abdominal Pain, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether a specific diet may help children with irritable bowel syndrome. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Irritable Bowel Syndrome, Abdominal Pain
- What is being tested?
- Low fermentable substrate diet and High fermentable substrate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to Dec 2017
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Must include all of the following:
- Children between the ages of 7-17 years;
- Meet the criteria for IBS based on the Questionnaire on Pediatric Gastrointestinal Symptoms Rome III Version, including pain/discomfort a minimum of twice per week;
- Negative physician evaluation for an organic etiology of the pain within the past year
Who cannot join
- Will include any of the following:
- Diabetes or other disease process requiring specialized dietary management;
- Malnutrition or obesity (BMI >95%);
- Inability to eat by mouth;
- Antibiotic or medicinal probiotic usage within the past 3 months (excluding yogurt);
- Neuromodulator (e.g. amitriptyline) usage within the past 3 months
- Start of, or change in gastrointestinal medication (e.g. laxative) dose that may cause or ameliorate abdominal symptoms within the past month
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Nutrition Research Center
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
About this study
The purpose of this study is to determine whether a specific diet may help children with irritable bowel syndrome.
Read the detailed description
Many children experience stomach pain or discomfort at some point during their lives. Some children have belly discomfort frequently while others rarely have this problem. There have been very few studies to test treatments for recurrent stomach discomfort in children. Recently, studies in adults with recurrent stomach discomfort suggest that diet changes may help. Currently, we do not know if these same diets will work in children with the same problem.
In this study, two different diets will be provided (delivered) for two days with at least 5 days in between each provided diet. The child's symptoms will be recorded over the two days of each diet. Children will be asked to capture samples of their breath during the last day of the each two day delivered diet. Stool samples will also be collected.
- Conditions
- Irritable Bowel Syndrome, Abdominal Pain
- Being tested
- Low fermentable substrate diet, High fermentable substrate diet
- Keywords
- irritable bowel syndrome, children, chronic abdominal pain, recurrent abdominal pain
- Medical subject headings
- Irritable Bowel Syndrome, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low fermentable substrate dietOther
Diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols.
High fermentable substrate dietOther
Diet high in fermentable oligosaccharides, disaccharides, monosaccharides and polyols
| Study group | Role | What they receive |
|---|---|---|
| High fermentable substrate diet | Experimental | High fermentable substrate diet provided for two days Receives: Other: High fermentable substrate diet |
| Low fermentable substrate diet | Experimental | Low fermentable substrate diet provided for two days Receives: Other: Low fermentable substrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily abdominal pain frequency
Comparisons of abdominal pain frequency (number of abdominal pain episodes per day) will be made between each two day dietary period spanning a 9 days.
Measured: 9 days (2 dietary intervention periods)
Secondary outcomes (2)
Abdominal pain severity
The severity of abdominal pain episodes will be measured on a 1-10 (10 being most severe) ordinal scale. Average severity per abdominal pain episode during each two day dietary period will be compared over 9 days.
Measured: 9 days (2 dietary intervention periods)
Hydrogen gas production
Daily hydrogen gas production (parts per million) will be compared between each 2 day dietary intervention period over 9 days.
Measured: 9 days (2 dietary intervention periods)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- NASPGHAN Foundation
- Responsible party
- Principal investigator, Bruno Chumpitazi, Baylor College of Medicine
- Investigators
- Bruno P Chumpitazi, MD, MPH, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339117
- Sponsor's protocol ID
- H-28050
- Status last verified
- Jan 2021
- First submitted
- 14 Apr 2011
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Chumpitazi BP, Cope JL, Hollister EB, Tsai CM, McMeans AR, Luna RA, Versalovic J, Shulman RJ. Randomised clinical trial: gut microbiome biomarkers are associated with clinical response to a low FODMAP diet in children with the irritable bowel syndrome. Aliment Pharmacol Ther. 2015 Aug;42(4):418-27. doi: 10.1111/apt.13286. Epub 2015 Jun 24.
PubMed 26104013
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivered Dietary Intervention for Children With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01339117
- Acronym / sponsor ID
- H-28050
- Conditions
- Irritable Bowel Syndrome, Abdominal Pain
- Keywords
- irritable bowel syndrome, children, chronic abdominal pain, recurrent abdominal pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- NASPGHAN Foundation
- Study start
- Jan 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 20 Apr 2011 (estimated)
- 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.
The purpose of this study is to determine whether a specific diet may help children with irritable bowel syndrome.
Detailed description
Many children experience stomach pain or discomfort at some point during their lives. Some children have belly discomfort frequently while others rarely have this problem. There have been very few studies to test treatments for recurrent stomach discomfort in children. Recently, studies in adults with recurrent stomach discomfort suggest that diet changes may help. Currently, we do not know if these same diets will work in children with the same problem.
In this study, two different diets will be provided (delivered) for two days with at least 5 days in between each provided diet. The child's symptoms will be recorded over the two days of each diet. Children will be asked to capture samples of their breath during the last day of the each two day delivered diet. Stool samples will also be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fermentable substrate diet | Experimental | Other: High fermentable substrate dietHigh fermentable substrate diet provided for two days |
| Low fermentable substrate diet | Experimental | Other: Low fermentable substrate dietLow fermentable substrate diet provided for two days |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children between the ages of 7-17 years;
- Meet the criteria for IBS based on the Questionnaire on Pediatric Gastrointestinal Symptoms Rome III Version, including pain/discomfort a minimum of twice per week;
- Negative physician evaluation for an organic etiology of the pain within the past year
Key exclusion criteria (7 listed)
- Diabetes or other disease process requiring specialized dietary management;
- Malnutrition or obesity (BMI >95%);
- Inability to eat by mouth;
- Antibiotic or medicinal probiotic usage within the past 3 months (excluding yogurt);
- Neuromodulator (e.g. amitriptyline) usage within the past 3 months
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 fermentable substrate dietDiet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols. | Other | Low fermentable substrate diet |
| High fermentable substrate dietDiet high in fermentable oligosaccharides, disaccharides, monosaccharides and polyols | Other | High fermentable substrate diet |
Primary outcome
Average daily abdominal pain frequency
Time frame: 9 days (2 dietary intervention periods)
Comparisons of abdominal pain frequency (number of abdominal pain episodes per day) will be made between each two day dietary period spanning a 9 days.
2 secondary outcomes
Abdominal pain severity
Time frame: 9 days (2 dietary intervention periods)
Hydrogen gas production
Time frame: 9 days (2 dietary intervention periods)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Derived from this study: PubMed 26104013Chumpitazi BP, Cope JL, Hollister EB, Tsai CM, McMeans AR, Luna RA, Versalovic J, Shulman RJ. Randomised clinical trial: gut microbiome biomarkers are associated with clinical response to a low FODMAP diet in children with the irritable bowel syndrome. Aliment Pharmacol Ther. 2015 Aug;42(4):418-27. doi: 10.1111/apt.13286. Epub 2015 Jun 24.
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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.
Bruno P Chumpitazi, MD, MPH principal investigator
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low fermentable substrate diet and High fermentable substrate diet in people with Irritable Bowel Syndrome and Abdominal Pain, run by Baylor College of Medicine at 2 sites in United States.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average daily abdominal pain frequency (time frame: 9 days (2 dietary intervention periods)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01339117, which also lists 1 linked publication.
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 22 Jan 2021.