Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00010933 |
| Other study ID # |
P50 AT000008-01P2 |
| Secondary ID |
P50 AT000008-01 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
February 2, 2001 |
| Last updated |
August 16, 2006 |
| Start date |
September 1998 |
| Est. completion date |
June 2004 |
Study information
| Verified date |
August 2006 |
| Source |
National Center for Complementary and Integrative Health (NCCIH) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to investigate novel methods from CAM aimed at alleviating
chronic pain related to functional bowel disorders in children. To that end, two CAM
modalities will be investigated independently of each other, namely Guided Imagery and the
use of Chamomile teas as a form of botanical therapy.
Functional abdominal pain is defined as pain unrelated to an identifiable organic
gastrointestinal disorder. The two subcategories of functional bowel disorders examined by
this study will be RAP and IBS. The definition of RAP in children will follow Apley's
classic definition of paroxysmal abdominal pain occurring in children between the ages of 4
and 16 years that persists for more than three months, with a frequency of three or more
episodes of abdominal pain over a three month interval. A similar pattern of abdominal pain
relieved by defecation and/or associated with altered bowel habits and/or stool consistency
will be defined as IBS. Despite the above definitions, note that the typical frequency of
pain episodes associated with functional bowel disorders is at least three times per month.
Description:
Functional bowl disorders are defined as variable combinations of gastrointestinal symptoms
that are not readily explained by structural or biochemical abnormalities. In children,
these typically encompass irritable bowel syndrome and recurrent abdominal pain of
childhood, two closely related disorders that reflect similar pathophysiologic processes.
Both of these functional disorders are pervasive in children and possibly precede symptoms
that persist into adulthood. These also account for considerable medical expense and
morbidity resulting in school absenteeism. Existing therapies are limited, and the lack of
success frequently frustrates parents, families, and physicians. The purpose of this pilot
project is to explore the use of alternative medicine modalities to treat functional
abdominal pain relying on those that address currently accepted pathophysiologic models of
functional bowel disorders. Available evidence indicates 3 major mechanisms for these
syndromes: altered intestinal motility, altered intestinal sensory thresholds, and
psychosocial factors. Recurrent abdominal pain occurs in 10 to 30 percent of children and
adolescents, and evidence suggests that many children with recurrent abdominal pain
ultimately develop symptoms compatible with irritable bowel syndrome in adulthood. As many
as 68% of school children suffering from recurrent abdominal pain have symptoms compatible
with the diagnostic criteria for irritable bowel syndrome in adults. Colonic motility
studies suggest exaggerated colonic motor function in patients with abdominal pain compared
to controls, increased perception of abdominal pain following balloon distention of the
rectum, and anxiety and depression compared to healthy children in the community. The
approach to therapy including reassurance, fiber, and antispasmodics has not been effective
in the long-term management of a recurrent abdominal pain in childhood.
Accordingly, this pilot project will attempt to evaluate objectively two alternative
modalities that address some of the mechanisms and could offer therapeutic options. In
specific aim 1, a randomized controlled trial will be instituted to confirm the
effectiveness of relaxation/guided imagery as a modality for treating functional bowel
disorders in children and determine if guided imagery improves outcome beyond that
achievable using relaxation training alone. In the second trial, the use of chamomile tea as
an adjunct to traditional modes of treating functional bowel disorders in children will be
assessed and compared to controls who do not receive chamomile tea. The primary outcome will
be a reduction in pain measured by a Likert-scale pain inventory using faces as markers. The
advantages of this inventory are that faces have been found to be universal across
ethnicities and age groups. Secondary outcomes will include bowel habits and stool
consistency, measures of functional disability using the Functional Disability Index, and
psychiatric profiles using the Child Depression Inventory, Revised Children's Manifest
Anxiety Scale, and Children's Global Assessment Scale. In addition, compliance measures will
be assessed by phone contact by nurse clinicians. Data management will be undertaken to
quantify the analyses already described.
Other known NCT identifiers
