Abdominal PainPhase 2NCT00526903
Recurrent Abdominal Pain in Children
A Phase 2 study testing Elimination Diet in people with Abdominal Pain and Irritable Bowel Syndrome, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to: 1. To determine if fiber versus placebo improves symptoms in children with recurrent abdominal pain/irritable bowel syndrome. 2. To determine possible ways fiber or placebo improve(s) symptoms in children with recurrent abdominal pain/irritable bowel syndrome by carrying out… Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Abdominal Pain, Irritable Bowel Syndrome
- What is being tested?
- Elimination Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Mar 2014
- Phase
- Phase 2
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children who have had at least one physician visit in the past year for abdominal pain or IBS symptoms.
- Children with recurrent abdominal pain who meet the criteria for irritable bowel syndrome.
Who cannot join
- Children who have another disease that accounts for stomach pain
- Current use of anti-inflammatory medication
- Children taking a GI medication that makes pain go away completely
- Children with other chronic conditions including chronic pain conditions (e.g. heart condition, diabetes)
- Children who have decreased growth
- GI blood loss
Show all 15Show fewer
- Unexplained fever
- Chronic severe diarrhea
- Weight loss of > or = to 5% of body weight within 3 month prior to enrollment
- History of abdominal surgeries
- A history of suicide
- Cognitive impairment significantly below average age and/or grade level
- Non-English speaking parent or child
- Vomiting >2x/month
- Children currently in psychotherapy for abdominal pain.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to:
- To determine if fiber versus placebo improves symptoms in children with recurrent abdominal pain/irritable bowel syndrome.
- To determine possible ways fiber or placebo improve(s) symptoms in children with recurrent abdominal pain/irritable bowel syndrome by carrying out gastrointestinal tests and questionnaires.
Read more
Understanding how diet and fiber affect GI function potentially will benefit the large numbers of children with irritable bowel syndrome (IBS) and provide insight into prevention of IBS in at risk children. We expect that the results from these studies can be used to lessen significantly the huge financial burden to society caused by these chronic conditions.
Consent will be obtained from the parent/guardian and assent from the child.
Read the detailed description
Children with recurrent abdominal pain (RAP) who meet the criteria for irritable bowel syndrome (IBS) will be recruited and studied. They will have been diagnosed by a pediatric gastroenterologist and will have had at least one healthcare visits in the past year for the complaint of abdominal pain.
Coordinators will come out to the family's home on an evening that is convenient. Both the parent and child will fill out some questionnaires. Next, the parent and child will get instructions on how to fill out a diary to record any stomach pain the child is having and what their stools look like. The child will also collect a stool sample during the regular diet and diary collection period. Once the child has completed the diary, the child will go on a special diet for eight days to remove foods that may cause stomach pain (foods and drinks containing lactose, fructose, and sorbitol will be eliminated).
Two weeks later, the coordinators will come out to the family's home again to review the pain and stool diary that the child kept while on the special diet. The coordinators will explain how to collect some samples of urine, stool, and breath. These tests will evaluate the gastrointestinal (GI) tract for inflammation and transit time. If the special diet does not make the stomach pain go away, the child will be selected at random, like the flip of a coin, to be placed in one of two groups: one group that receives fiber or one group that receives a placebo or sugar pill. Fiber has been suggested to help children with stomach pain.
After the child has been on the treatment for 6 weeks, he/she will keep another diary and collect another set of samples of urine, stool, and breath.
The children will be followed at 3 months, 6 months and 18 months after the treatment period.
Children will be asked to collect additional stools
- Conditions
- Abdominal Pain, Irritable Bowel Syndrome
- Being tested
- Elimination Diet
- Keywords
- IBS, abdominal pain, recurrent abdominal pain, irritable bowel syndrome, diarrhea, constipation, bloating
- Medical subject headings
- Abdominal Pain, Irritable Bowel Syndrome, Diarrhea, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elimination DietBehavioural
Daily diet change for 8 days.
| Study group | Role | What they receive |
|---|---|---|
| Fiber | Experimental | Fiber added to diet for a total of 6 weeks. Receives: Behavioral: Elimination Diet |
| Placebo | Placebo comparator | Placebo powder taken for a total of 6 weeks. Receives: Behavioral: Elimination Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in pain and stooling symptoms
Measured: The last two weeks of treatment and up to 18 months after treatment
Secondary outcomes (6)
Child anxiety, somatization, and coping
Measured: Four weeks prior to treatment and 6 months after treatment
Parental somatization, coping, and illness interaction
Measured: Four weeks prior to treatment and 6 months after treatment
Changes in GI Transit time
Measured: Prior to and after treatment
Changes in Breath Hydrogen production
Measured: Prior to and after treatment
Changes in GI Permeability
Measured: Prior to and after treatment
Changes in fecal calprotectin concentration
Measured: Prior to and after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startJan 2009
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Abdominal PainStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Robert Shulman, M.D., Baylor College of Medicine
- Investigators
- Robert Shulman, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526903
- Sponsor's protocol ID
- 17388
- Other IDs
- R01NR005337
- Status last verified
- Mar 2016
- First submitted
- 6 Sep 2007
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shulman RJ, Eakin MN, Jarrett M, Czyzewski DI, Zeltzer LK. Characteristics of pain and stooling in children with recurrent abdominal pain. J Pediatr Gastroenterol Nutr. 2007 Feb;44(2):203-8. doi: 10.1097/01.mpg.0000243437.39710.c0.
PubMed 17255832Thakkar K, Gilger MA, Shulman RJ, El Serag HB. EGD in children with abdominal pain: a systematic review. Am J Gastroenterol. 2007 Mar;102(3):654-61. doi: 10.1111/j.1572-0241.2007.01051.x.
PubMed 17222318Czyzewski DI, Eakin MN, Lane MM, Jarrett M, Shulman RJ, M D. Recurrent Abdominal Pain in Primary and Tertiary Care: Differences and Similarities. Child Health Care. 2007 May 2;36(2):137-153. doi: 10.1080/02739610701334970. No abstract available.
PubMed 20357915Jarrett M, Heitkemper M, Czyzewski DI, Shulman R. Recurrent abdominal pain in children: forerunner to adult irritable bowel syndrome? J Spec Pediatr Nurs. 2003 Jul-Sep;8(3):81-9. doi: 10.1111/j.1088-145x.2003.00081.x.
PubMed 12942886Burr RL, Motzer SA, Chen W, Cowan MJ, Shulman RJ, Heitkemper MM. Heart rate variability and 24-hour minimum heart rate. Biol Res Nurs. 2006 Apr;7(4):256-67. doi: 10.1177/1099800405285268.
PubMed 16581896McOmber ME, Shulman RJ. Recurrent abdominal pain and irritable bowel syndrome in children. Curr Opin Pediatr. 2007 Oct;19(5):581-5. doi: 10.1097/MOP.0b013e3282bf6ddc.
PubMed 17885479Kellermayer R, Tatevian N, Klish W, Shulman RJ. Steroid responsive eosinophilic gastric outlet obstruction in a child. World J Gastroenterol. 2008 Apr 14;14(14):2270-1. doi: 10.3748/wjg.14.2270.
PubMed 18407608Amaizu N, Shulman R, Schanler R, Lau C. Maturation of oral feeding skills in preterm infants. Acta Paediatr. 2008 Jan;97(1):61-7. doi: 10.1111/j.1651-2227.2007.00548.x. Epub 2007 Dec 3.
PubMed 18052999McOmber MA, Shulman RJ. Pediatric functional gastrointestinal disorders. Nutr Clin Pract. 2008 Jun-Jul;23(3):268-74. doi: 10.1177/0884533608318671.
PubMed 18595859Shulman RJ, Eakin MN, Czyzewski DI, Jarrett M, Ou CN. Increased gastrointestinal permeability and gut inflammation in children with functional abdominal pain and irritable bowel syndrome. J Pediatr. 2008 Nov;153(5):646-50. doi: 10.1016/j.jpeds.2008.04.062. Epub 2008 Jun 9.
PubMed 18538790Lane MM, Weidler EM, Czyzewski DI, Shulman RJ. Pain symptoms and stooling patterns do not drive diagnostic costs for children with functional abdominal pain and irritable bowel syndrome in primary or tertiary care. Pediatrics. 2009 Mar;123(3):758-64. doi: 10.1542/peds.2008-0227.
PubMed 19254999So SY, Badu S, Wu Q, Yalcinkaya N, Mirabile Y, Castaneda R, Musaad S, Heitkemper M, Savidge TC, Shulman RJ. Sex-Dependent Efficacy of Dietary Fiber in Pediatric Functional Abdominal Pain. Gastroenterology. 2024 Apr;166(4):645-657.e14. doi: 10.1053/j.gastro.2023.12.011. Epub 2023 Dec 19.
PubMed 38123024Shulman RJ, Hollister EB, Cain K, Czyzewski DI, Self MM, Weidler EM, Devaraj S, Luna RA, Versalovic J, Heitkemper M. Psyllium Fiber Reduces Abdominal Pain in Children With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial. Clin Gastroenterol Hepatol. 2017 May;15(5):712-719.e4. doi: 10.1016/j.cgh.2016.03.045. Epub 2016 Apr 11.
PubMed 27080737
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent Abdominal Pain in Children
- ClinicalTrials.gov ID
- NCT00526903
- Acronym / sponsor ID
- 17388
- Conditions
- Abdominal Pain, Irritable Bowel Syndrome
- Keywords
- IBS, abdominal pain, recurrent abdominal pain, irritable bowel syndrome, diarrhea, constipation, bloating
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jan 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 10 Sep 2007 (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:
- To determine if fiber versus placebo improves symptoms in children with recurrent abdominal pain/irritable bowel syndrome.
- To determine possible ways fiber or placebo improve(s) symptoms in children with recurrent abdominal pain/irritable bowel syndrome by carrying out gastrointestinal tests and questionnaires.
Understanding how diet and fiber affect GI function potentially will benefit the large numbers of children with irritable bowel syndrome (IBS) and provide insight into prevention of IBS in at risk children. We expect that the results from these studies can be used to lessen significantly the huge financial burden to society caused by these chronic conditions.
Consent will be obtained from the parent/guardian and assent from the child.
Detailed description
Children with recurrent abdominal pain (RAP) who meet the criteria for irritable bowel syndrome (IBS) will be recruited and studied. They will have been diagnosed by a pediatric gastroenterologist and will have had at least one healthcare visits in the past year for the complaint of abdominal pain.
Coordinators will come out to the family's home on an evening that is convenient. Both the parent and child will fill out some questionnaires. Next, the parent and child will get instructions on how to fill out a diary to record any stomach pain the child is having and what their stools look like. The child will also collect a stool sample during the regular diet and diary collection period. Once the child has completed the diary, the child will go on a special diet for eight days to remove foods that may cause stomach pain (foods and drinks containing lactose, fructose, and sorbitol will be eliminated).
Two weeks later, the coordinators will come out to the family's home again to review the pain and stool diary that the child kept while on the special diet. The coordinators will explain how to collect some samples of urine, stool, and breath. These tests will evaluate the gastrointestinal (GI) tract for inflammation and transit time. If the special diet does not make the stomach pain go away, the child will be selected at random, like the flip of a coin, to be placed in one of two groups: one group that receives fiber or one group that receives a placebo or sugar pill. Fiber has been suggested to help children with stomach pain.
After the child has been on the treatment for 6 weeks, he/she will keep another diary and collect another set of samples of urine, stool, and breath.
The children will be followed at 3 months, 6 months and 18 months after the treatment period.
Children will be asked to collect additional stools
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiber | Experimental | Behavioral: Elimination DietFiber added to diet for a total of 6 weeks. |
| Placebo | Placebo comparator | Behavioral: Elimination DietPlacebo powder taken for a total of 6 weeks. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children who have had at least one physician visit in the past year for abdominal pain or IBS symptoms.
- Children with recurrent abdominal pain who meet the criteria for irritable bowel syndrome.
Key exclusion criteria (15 listed)
- Children who have another disease that accounts for stomach pain
- Current use of anti-inflammatory medication
- Children taking a GI medication that makes pain go away completely
- Children with other chronic conditions including chronic pain conditions (e.g. heart condition, diabetes)
- Children who have decreased growth
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 |
|---|---|---|
| Elimination DietDaily diet change for 8 days. | Behavioural | Fiber, Placebo |
Primary outcome
Improvement in pain and stooling symptoms
Time frame: The last two weeks of treatment and up to 18 months after treatment
6 secondary outcomes
Child anxiety, somatization, and coping
Time frame: Four weeks prior to treatment and 6 months after treatment
Parental somatization, coping, and illness interaction
Time frame: Four weeks prior to treatment and 6 months after treatment
Changes in GI Transit time
Time frame: Prior to and after treatment
Changes in Breath Hydrogen production
Time frame: Prior to and after treatment
Changes in GI Permeability
Time frame: Prior to and after treatment
Changes in fecal calprotectin concentration
Time frame: Prior to and after treatment
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 8 Mar 2016.
- Background: PubMed 17255832Shulman RJ, Eakin MN, Jarrett M, Czyzewski DI, Zeltzer LK. Characteristics of pain and stooling in children with recurrent abdominal pain. J Pediatr Gastroenterol Nutr. 2007 Feb;44(2):203-8. doi: 10.1097/01.mpg.0000243437.39710.c0.
- Background: PubMed 17222318Thakkar K, Gilger MA, Shulman RJ, El Serag HB. EGD in children with abdominal pain: a systematic review. Am J Gastroenterol. 2007 Mar;102(3):654-61. doi: 10.1111/j.1572-0241.2007.01051.x.
- Background: PubMed 20357915Czyzewski DI, Eakin MN, Lane MM, Jarrett M, Shulman RJ, M D. Recurrent Abdominal Pain in Primary and Tertiary Care: Differences and Similarities. Child Health Care. 2007 May 2;36(2):137-153. doi: 10.1080/02739610701334970. No abstract available.
- Background: PubMed 12942886Jarrett M, Heitkemper M, Czyzewski DI, Shulman R. Recurrent abdominal pain in children: forerunner to adult irritable bowel syndrome? J Spec Pediatr Nurs. 2003 Jul-Sep;8(3):81-9. doi: 10.1111/j.1088-145x.2003.00081.x.
- Background: PubMed 16581896Burr RL, Motzer SA, Chen W, Cowan MJ, Shulman RJ, Heitkemper MM. Heart rate variability and 24-hour minimum heart rate. Biol Res Nurs. 2006 Apr;7(4):256-67. doi: 10.1177/1099800405285268.
- Background: PubMed 17885479McOmber ME, Shulman RJ. Recurrent abdominal pain and irritable bowel syndrome in children. Curr Opin Pediatr. 2007 Oct;19(5):581-5. doi: 10.1097/MOP.0b013e3282bf6ddc.
- Background: PubMed 18407608Kellermayer R, Tatevian N, Klish W, Shulman RJ. Steroid responsive eosinophilic gastric outlet obstruction in a child. World J Gastroenterol. 2008 Apr 14;14(14):2270-1. doi: 10.3748/wjg.14.2270.
- Background: PubMed 18052999Amaizu N, Shulman R, Schanler R, Lau C. Maturation of oral feeding skills in preterm infants. Acta Paediatr. 2008 Jan;97(1):61-7. doi: 10.1111/j.1651-2227.2007.00548.x. Epub 2007 Dec 3.
- Background: PubMed 18595859McOmber MA, Shulman RJ. Pediatric functional gastrointestinal disorders. Nutr Clin Pract. 2008 Jun-Jul;23(3):268-74. doi: 10.1177/0884533608318671.
- Background: PubMed 18538790Shulman RJ, Eakin MN, Czyzewski DI, Jarrett M, Ou CN. Increased gastrointestinal permeability and gut inflammation in children with functional abdominal pain and irritable bowel syndrome. J Pediatr. 2008 Nov;153(5):646-50. doi: 10.1016/j.jpeds.2008.04.062. Epub 2008 Jun 9.
- Background: PubMed 19254999Lane MM, Weidler EM, Czyzewski DI, Shulman RJ. Pain symptoms and stooling patterns do not drive diagnostic costs for children with functional abdominal pain and irritable bowel syndrome in primary or tertiary care. Pediatrics. 2009 Mar;123(3):758-64. doi: 10.1542/peds.2008-0227.
- Derived from this study: PubMed 38123024So SY, Badu S, Wu Q, Yalcinkaya N, Mirabile Y, Castaneda R, Musaad S, Heitkemper M, Savidge TC, Shulman RJ. Sex-Dependent Efficacy of Dietary Fiber in Pediatric Functional Abdominal Pain. Gastroenterology. 2024 Apr;166(4):645-657.e14. doi: 10.1053/j.gastro.2023.12.011. Epub 2023 Dec 19.
- Information about Kids GI HealthLink provided by the sponsor.
- Information about Children in Clinical ResearchLink provided by the sponsor.
- Our research group's website at Baylor College of MedicineLink provided by the sponsor.
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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.
Robert Shulman principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elimination Diet in people with Abdominal Pain and Irritable Bowel Syndrome, run by Baylor College of Medicine at 1 site 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 2 inclusion and 15 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 8 Mar 2016. 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improvement in pain and stooling symptoms (time frame: The last two weeks of treatment and up to 18 months after treatment). 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 NCT00526903, which also lists 13 linked publications.
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 8 Mar 2016; AzTrials last refreshed its copy on 30 Oct 2026.