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CompletedNCT00619970CAP&SIBOUpdated Feb 16, 2017Results posted

Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth?

An interventional study of Lactulose Breath Test and xifaxan in Chronic Abdominal Pain and Small Intestinal Bacterial Overgrowth, sponsored by Children's Hospital Los Angeles. Completed at 1 site in United States. Open to participants aged 8 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-16.

Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
115
Allocation
Randomized
Ages
8 Years to 18 Years
Sex
All
01

Study summary

Chronic abdominal pain (CAP) is an extremely pervasive childhood condition and, like IBS in adults, it is one of the functional bowel disorders without a clear framework of understanding or an effective treatment. However, new research suggests that small intestinal bacterial overgrowth (SIBO) may be the unifying pathophysiology that explains the variety of symptoms experienced by patients with IBS. As CAP in children is believed to be a precursor to IBS in adults, we hypothesize that children with this disorder have a significantly greater prevalence of small intestinal bacterial overgrowth (SIBO) than normal, healthy children, and that eradication of bacterial overgrowth with antibiotics will reduce symptoms of chronic abdominal pain in children with this condition. To prove this, we will first aim to determine the prevalence of SIBO in both healthy children and those with CAP. We will do this by performing a lactulose breath hydrogen test, the gold standard for the noninvasive measurement of SIBO, on 40 healthy controls and 80 subjects with CAP. We will then assess whether eradication of SIBO with antibiotics will reduce symptoms of chronic abdominal pain in children with this condition. To do this we will randomize, in a double-blinded fashion, the 80 CAP patients to receive a 10-day course of either the antibiotic Rifaximin or a placebo. After completion of the treatment we will evaluate all these patients for eradication of bacterial overgrowth by repeating a lactulose breath hydrogen test. We will also assess for symptom improvement by re-administering questionnaires.

02

Conditions studied

  • Chronic Abdominal Pain
  • Small Intestinal Bacterial Overgrowth

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03

In context

Abdominal Pain

338 studies on the registry are indexed under Abdominal Pain; 55 are open to participants now.

This study's enrollment of 115 is above the median of 72 across 250 interventional studies indexed under Abdominal Pain.

Browse Abdominal Pain studies →

Lead sponsor

Children's Hospital Los Angeles is the lead sponsor of 150 studies on the registry; 46 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subjects must be between the ages of 8 and 18
  • Subjects must be able to swallow pills
  • Healthy Controls must be siblings, other family members or friends of the CAP subjects or children who are undergoing an overnight fast in order to obtain AM labs for another purpose other than this study.
  • Female CAP subjects who are sexually active or who may become sexually active during the study will be required to practice an effective method of birth control (e.g., oral contraceptives, contraceptive patch or injection, IUD, double barrier method) before entering into the study.
  • All CAP subjects must meet the Rome II Criteria for Functional Bowel Disorders Associated with Abdominal Pain or Discomfort in Children

Exclusion criteria

Exclusion Criteria:

Subjects will be excluded if they:

  • have a history of inflammatory bowel diseases, diabetes, cirrhosis or other liver disease, juvenile rheumatoid arthritis, systemic lupus, a history of bowel resection (including gastric, small bowel or colon; gallbladder surgery or appendectomy are NOT exclusion criteria).
  • have been treated with antibiotics or probiotics within the past 2 months.
  • have a history of TB infection or positive Mantoux test performed at screening
  • have a history of allergy to rifampin or rifaximin
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
115 participants (actual)

Study arms

  • Active comparator
    Healthy Control

    Healthy controls

    Procedure: Lactulose Breath Test

  • Active comparator
    Children receiving Rifaximin

    2/3 Patients with CAP

    Drug: xifaxan · Procedure: Lactulose Breath Test

  • Placebo comparator
    Children receiving Placebo

    1/3 patients with CAP

    Drug: placebo · Procedure: Lactulose Breath Test

Interventions

  • ProcedureLactulose Breath Test

    Healthy controls will receive one lactulose breath test to assess for SIBO

  • Drugxifaxan

    xifaxan 550mg TID x10days

  • Drugplacebo

    placebo TID x 10days

  • ProcedureLactulose Breath Test

    Children with CAP will receive one lactulose breath test to assess for SIBO and one after receiving either Rifaximin or Placebo

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What researchers measure

Primary outcomes

  1. The Number of Participants at Baseline With SIBO

    Time frame: upon enrollment

  2. Number of Participants With SIBO at Baseline (Week 0) and at 2 Week Post Treatment

    Time frame: baseline (week 0) and at 2 weeks post treatment

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Results

Posted Feb 16, 2017

Participant flow

Participant flow — Overall Study
MilestoneHealthy ControlChildren Receiving RifaximinChildren Receiving Placebo
Started404926
Completed404624
Not completed032

Outcome measures

PrimaryThe Number of Participants at Baseline With SIBO
Time frame:
upon enrollment
Reported as:
Count of participants · Participants
The Number of Participants at Baseline With SIBO
ParticipantsHealthy ControlChildren Receiving RifaximinChildren Receiving Placebo
The Number of Participants at Baseline With SIBO144424
PrimaryNumber of Participants With SIBO at Baseline (Week 0) and at 2 Week Post Treatment
Time frame:
baseline (week 0) and at 2 weeks post treatment
Reported as:
Count of participants · Participants
Number of Participants With SIBO at Baseline (Week 0) and at 2 Week Post Treatment
ParticipantsChildren Receiving RifaximinChildren Receiving Placebo
At baseline4424
2 weeks3719

Adverse events

Collected over 8 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Healthy Control—0/40 (0%)0/40 (0%)
Children Receiving Rifaximin—0/49 (0%)0/49 (0%)
Children Receiving Placebo—0/26 (0%)0/26 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Healthy ControlChildren Receiving RifaximinChildren Receiving PlaceboTotal
<=18 years404926115
Between 18 and 65 years0000
>=65 years0000
Sex: Female, Male
Sex: Female, Male(Participants)Healthy ControlChildren Receiving RifaximinChildren Receiving PlaceboTotal
Female25371880
Male1512835
Region of Enrollment
Region of Enrollment(participants)Healthy ControlChildren Receiving RifaximinChildren Receiving PlaceboTotal
United States404926115
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Study locations

1 site
  • Childrens Hospital Los Angeles
    Los Angeles, California 90027, United States
09

References and documents

Publications

  • Collins BS, Lin HC. Double-blind, placebo-controlled antibiotic treatment study of small intestinal bacterial overgrowth in children with chronic abdominal pain. J Pediatr Gastroenterol Nutr. 2011 Apr;52(4):382-6. doi: 10.1097/MPG.0b013e3181effa3b. PubMed 21240023 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00619970
Lead sponsor
Children's Hospital Los Angeles
Responsible party
Brynie Collins (Assistant Professor of Pediatrics, Children's Hospital Los Angeles) — Principal investigator
First posted
Feb 21, 2008
Start date
Feb 2007
Primary completion
Sep 2008
Completion
Sep 2008
Results posted
Feb 16, 2017
Last update
Feb 16, 2017

Study contacts

Brynie S Collins, MD
principal investigator · Children's Hospital Los Angeles

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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