Recurrent Abdominal Pain in Children
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00526903 |
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Recruitment Status :
Completed
First Posted : September 10, 2007
Last Update Posted : March 8, 2016
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Abdominal Pain Irritable Bowel Syndrome | Behavioral: Elimination Diet | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 168 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Diagnostic |
| Official Title: | Recurrent Abdominal Pain in Children |
| Study Start Date : | January 2009 |
| Actual Primary Completion Date : | March 2014 |
| Actual Study Completion Date : | March 2014 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Fiber
Fiber added to diet for a total of 6 weeks.
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Behavioral: Elimination Diet
Daily diet change for 8 days. |
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Placebo Comparator: Placebo
Placebo powder taken for a total of 6 weeks.
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Behavioral: Elimination Diet
Daily diet change for 8 days. |
- Improvement in pain and stooling symptoms [ Time Frame: The last two weeks of treatment and up to 18 months after treatment ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 7 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526903
| United States, Texas | |
| Texas Children's Hospital | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Robert Shulman | Baylor College of Medicine |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Robert Shulman, M.D., Professor of Pediatrics, Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00526903 |
| Other Study ID Numbers: |
17388 R01NR005337 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 10, 2007 Key Record Dates |
| Last Update Posted: | March 8, 2016 |
| Last Verified: | March 2016 |
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IBS abdominal pain recurrent abdominal pain irritable bowel syndrome |
diarrhea constipation bloating |
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Irritable Bowel Syndrome Abdominal Pain Colonic Diseases, Functional Colonic Diseases Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Pain Neurologic Manifestations Signs and Symptoms, Digestive |