Recurrent Abdominal Pain in Children
| Status: | Completed |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Pain |
| Therapuetic Areas: | Gastroenterology, Musculoskeletal |
| Healthy: | No |
| Age Range: | 7 - 18 |
| Updated: | 4/21/2016 |
| Start Date: | January 2009 |
| End Date: | March 2014 |
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 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.
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 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.
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
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
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.
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