Irritable Bowel Syndrome (IBS)NCT02842281
Microbiome Fructan Metabolism and Symptoms in Childhood IBS
A study testing Fructan and Maltodextrin in people with Irritable Bowel Syndrome (IBS), run by Baylor College of Medicine at 2 sites in United States.
Trial summary
This study evaluates whether the gut microbiome is involved in determining whether children with irritable bowel syndrome (IBS) develop worsening GI symptoms (e.g. pain) when given fructans (a sugar often found in wheat). Participants will both receive a diet with fructans and a diet without fructans. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- What is being tested?
- Fructan and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to Dec 2019
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Children ages 7-17 years
- Children with IBS will meet Rome III criteria per the Rome III questionnaire
- Healthy children will not have chronic conditions
- English speaking and able to read/write in English
Who cannot join
- Previous bowel surgery
- Documented gastrointestinal disorder (e.g. ulcerative colitis)
- Serious chronic medical condition (e.g. diabetes)
- Weight and/or height are greater than or less than 2 standard deviations for age
- Chronic conditions with GI symptoms (e.g. cystic fibrosis)
- Antibiotics within the past 3 months
Show all 10Show fewer
- Pregnancy
- Autism spectrum disorder and/or significant developmental delay
- Mood disorders (e.g. major depression)
- Known post-infectious etiology
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
Official title: Intestinal Microbiome Fructan Metabolism and Symptom Generation in Childhood IBS
This study evaluates whether the gut microbiome is involved in determining whether children with irritable bowel syndrome (IBS) develop worsening GI symptoms (e.g. pain) when given fructans (a sugar often found in wheat). Participants will both receive a diet with fructans and a diet without fructans.
Read the detailed description
Fructans (fructo-oligosaccharides) are a type of carbohydrate which can not be hydrolyzed by humans. It is commonly found in wheat in the American diet. After ingestion they arrive essentially intact into the colon where they are metabolized by the colonic microbiome. Fructan avoidance has been found to help decrease gastrointestinal symptoms (e.g. pain) in those with IBS.
However not all individuals with IBS have worsening symptoms when eating fructans in their diet. This study seeks to evaluate whether the microbiome is involved in determining whether an individual with IBS has worsening symptoms with fructan ingestion.
Following a one week baseline period, participants will be randomized in a double-blind cross-over fashion to either a 72 hour meal period with fructans or a 72 hour meal period with maltodextrin (placebo). A washout period of at least 10 days will occur in between. Symptoms will be captured using a stool and pain diary. Stool specimens and urine specimens will be obtained at baseline and during the dietary interventions. Breath hydrogen testing will be obtained during the dietary interventions.
- Conditions
- Irritable Bowel Syndrome (IBS)
- Being tested
- Fructan, Maltodextrin
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FructanOther
Also called fructo-oligosaccharides
Short-chain oligosaccharide primarily composed of fructose polymers
MaltodextrinOther
Polysaccharide produced from starch
| Study group | Role | What they receive |
|---|---|---|
| Fructan | Active comparator | Fructans will be provided for 72 hours. Receives: Other: Fructan |
| Maltodextrin | Placebo comparator | Maltodextrin will be provided for 72 hours. Receives: Other: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operational Taxonomic Units (microbiome composition derived from 16s rRNA sequencing)
Children with IBS who have worsening GI symptoms with fructans vs. those who do not
Measured: Three days
Microbiome metabolic signatures related to fructan metabolism
Children with IBS who have worsening GI symptoms with fructans vs. those who do not
Measured: Three days
Metabolic products of fructan metabolism
In those with IBS who have worsening symptoms when given fructans, the investigators will correlate fructan metabolic byproducts with GI symptoms (e.g. pain)
Measured: Three days
Secondary outcomes (4)
Microbiome related signatures
Healthy children will have their microbiome signatures (composition, metabolic signatures related to fructan metabolism, and metabolic products of fructan metabolism) compared to children with IBS
Measured: Three days
Overall microbiome metabolic signatures
Children with IBS who have worsening GI symptoms vs. those who do not
Measured: Three days
Overall metabolic products
Following a fructan challenge in children with IBS who develop worsening GI symptoms vs. those who do not
Measured: Three days
Breath hydrogen and methane production symptoms
Children with IBS who have worsening GI symptoms when given fructans vs. those who do not
Measured: Three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startSep 2014
- Primary completionMar 2019
- Study completionDec 2019
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 Syndrome (IBS)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Chumpitazi, Baylor College of Medicine
- Investigators
- Bruno Chumpitazi, MD, MPH, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842281
- Sponsor's protocol ID
- H-34372
- Other IDs
- K23DK101688
- Status last verified
- Jan 2021
- First submitted
- 15 Jul 2016
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Chumpitazi BP, McMeans AR, Vaughan A, Ali A, Orlando S, Elsaadi A, Shulman RJ. Fructans Exacerbate Symptoms in a Subset of Children With Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2018 Feb;16(2):219-225.e1. doi: 10.1016/j.cgh.2017.09.043. Epub 2017 Sep 29.
PubMed 28970147
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
- Intestinal Microbiome Fructan Metabolism and Symptom Generation in Childhood IBS
- ClinicalTrials.gov ID
- NCT02842281
- Acronym / sponsor ID
- H-34372
- Conditions
- Irritable Bowel Syndrome (IBS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2014
- Primary completion
- Mar 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 22 Jul 2016 (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.
This study evaluates whether the gut microbiome is involved in determining whether children with irritable bowel syndrome (IBS) develop worsening GI symptoms (e.g. pain) when given fructans (a sugar often found in wheat). Participants will both receive a diet with fructans and a diet without fructans.
Detailed description
Fructans (fructo-oligosaccharides) are a type of carbohydrate which can not be hydrolyzed by humans. It is commonly found in wheat in the American diet. After ingestion they arrive essentially intact into the colon where they are metabolized by the colonic microbiome. Fructan avoidance has been found to help decrease gastrointestinal symptoms (e.g. pain) in those with IBS.
However not all individuals with IBS have worsening symptoms when eating fructans in their diet. This study seeks to evaluate whether the microbiome is involved in determining whether an individual with IBS has worsening symptoms with fructan ingestion.
Following a one week baseline period, participants will be randomized in a double-blind cross-over fashion to either a 72 hour meal period with fructans or a 72 hour meal period with maltodextrin (placebo). A washout period of at least 10 days will occur in between. Symptoms will be captured using a stool and pain diary. Stool specimens and urine specimens will be obtained at baseline and during the dietary interventions. Breath hydrogen testing will be obtained during the dietary interventions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fructan | Active comparator | Other: FructanFructans will be provided for 72 hours. |
| Maltodextrin | Placebo comparator | Other: MaltodextrinMaltodextrin will be provided for 72 hours. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children ages 7-17 years
- Children with IBS will meet Rome III criteria per the Rome III questionnaire
- Healthy children will not have chronic conditions
- English speaking and able to read/write in English
Key exclusion criteria (10 listed)
- Previous bowel surgery
- Documented gastrointestinal disorder (e.g. ulcerative colitis)
- Serious chronic medical condition (e.g. diabetes)
- Weight and/or height are greater than or less than 2 standard deviations for age
- Chronic conditions with GI symptoms (e.g. cystic fibrosis)
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 |
|---|---|---|
| FructanAlso: fructo-oligosaccharidesShort-chain oligosaccharide primarily composed of fructose polymers | Other | Fructan |
| MaltodextrinPolysaccharide produced from starch | Other | Maltodextrin |
Primary outcome
Operational Taxonomic Units (microbiome composition derived from 16s rRNA sequencing)
Time frame: Three days
Children with IBS who have worsening GI symptoms with fructans vs. those who do not
Microbiome metabolic signatures related to fructan metabolism
Time frame: Three days
Children with IBS who have worsening GI symptoms with fructans vs. those who do not
Metabolic products of fructan metabolism
Time frame: Three days
In those with IBS who have worsening symptoms when given fructans, the investigators will correlate fructan metabolic byproducts with GI symptoms (e.g. pain)
4 secondary outcomes
Microbiome related signatures
Time frame: Three days
Overall microbiome metabolic signatures
Time frame: Three days
Overall metabolic products
Time frame: Three days
Breath hydrogen and methane production symptoms
Time frame: Three days
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 28970147Chumpitazi BP, McMeans AR, Vaughan A, Ali A, Orlando S, Elsaadi A, Shulman RJ. Fructans Exacerbate Symptoms in a Subset of Children With Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2018 Feb;16(2):219-225.e1. doi: 10.1016/j.cgh.2017.09.043. Epub 2017 Sep 29.
- Individual participant dataSharing planned: Yes
Related trials for Irritable Bowel Syndrome (IBS)
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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 Chumpitazi, MD, MPH principal investigator
Assistant Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fructan and Maltodextrin in people with Irritable Bowel Syndrome (IBS), 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 10 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. Some participants in this study may receive a placebo. 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?
Operational Taxonomic Units (microbiome composition derived from 16s rRNA sequencing) (time frame: Three days). The study lists 3 primary outcomes in all. 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 NCT02842281, 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.