Recurrent Abdominal Pain in Children
Primary Purpose
Abdominal Pain, Irritable Bowel Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Elimination Diet
Sponsored by
About this trial
This is an interventional diagnostic trial for Abdominal Pain focused on measuring IBS, abdominal pain, recurrent abdominal pain, irritable bowel syndrome, diarrhea, constipation, bloating
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- Texas Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fiber
Placebo
Arm Description
Fiber added to diet for a total of 6 weeks.
Placebo powder taken for a total of 6 weeks.
Outcomes
Primary Outcome Measures
Improvement in pain and stooling symptoms
Secondary Outcome Measures
Child anxiety, somatization, and coping
Parental somatization, coping, and illness interaction
Changes in GI Transit time
Changes in Breath Hydrogen production
Changes in GI Permeability
Changes in fecal calprotectin concentration
Full Information
NCT ID
NCT00526903
First Posted
September 6, 2007
Last Updated
March 4, 2016
Sponsor
Baylor College of Medicine
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT00526903
Brief Title
Recurrent Abdominal Pain in Children
Official Title
Recurrent Abdominal Pain in Children
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain, Irritable Bowel Syndrome
Keywords
IBS, abdominal pain, recurrent abdominal pain, irritable bowel syndrome, diarrhea, constipation, bloating
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fiber
Arm Type
Experimental
Arm Description
Fiber added to diet for a total of 6 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo powder taken for a total of 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Elimination Diet
Intervention Description
Daily diet change for 8 days.
Primary Outcome Measure Information:
Title
Improvement in pain and stooling symptoms
Time Frame
The last two weeks of treatment and up to 18 months after treatment
Secondary Outcome Measure Information:
Title
Child anxiety, somatization, and coping
Time Frame
Four weeks prior to treatment and 6 months after treatment
Title
Parental somatization, coping, and illness interaction
Time Frame
Four weeks prior to treatment and 6 months after treatment
Title
Changes in GI Transit time
Time Frame
Prior to and after treatment
Title
Changes in Breath Hydrogen production
Time Frame
Prior to and after treatment
Title
Changes in GI Permeability
Time Frame
Prior to and after treatment
Title
Changes in fecal calprotectin concentration
Time Frame
Prior to and after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Shulman
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17255832
Citation
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.
Results Reference
background
PubMed Identifier
17222318
Citation
Thakkar 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.
Results Reference
background
PubMed Identifier
20357915
Citation
Czyzewski 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.
Results Reference
background
PubMed Identifier
12942886
Citation
Jarrett 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.
Results Reference
background
PubMed Identifier
16581896
Citation
Burr 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.
Results Reference
background
PubMed Identifier
17885479
Citation
McOmber 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.
Results Reference
background
PubMed Identifier
18407608
Citation
Kellermayer 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.
Results Reference
background
PubMed Identifier
18052999
Citation
Amaizu 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.
Results Reference
background
PubMed Identifier
18595859
Citation
McOmber MA, Shulman RJ. Pediatric functional gastrointestinal disorders. Nutr Clin Pract. 2008 Jun-Jul;23(3):268-74. doi: 10.1177/0884533608318671.
Results Reference
background
PubMed Identifier
18538790
Citation
Shulman 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.
Results Reference
background
PubMed Identifier
19254999
Citation
Lane 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.
Results Reference
background
PubMed Identifier
27080737
Citation
Shulman 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.
Results Reference
derived
Links:
URL
http://www.aboutkidsgi.org/
Description
Information about Kids GI Health
URL
http://www.childrenandclinicalstudies.nhlbi.nih.gov
Description
Information about Children in Clinical Research
URL
http://www.bcm.edu/cnrc/kidsabdominalpain
Description
Our research group's website at Baylor College of Medicine
Learn more about this trial
Recurrent Abdominal Pain in Children
We'll reach out to this number within 24 hrs