Recurrent Abdominal Pain in Children

NCT00526903 | Completed Phase 2 DMC

• 2 other identifiers: 17388R01NR005337
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to:

1. 1.To determine if fiber versus placebo improves symptoms in children with recurrent abdominal pain/irritable bowel syndrome.
2. 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.

Conditions

Abdominal Pain; Irritable Bowel Syndrome

Keywords

IBS; abdominal pain; recurrent abdominal pain; irritable bowel syndrome; diarrhea; constipation; bloating

Outcome Measures

Primary Outcomes (1)

• Improvement in pain and stooling symptoms

  The last two weeks of treatment and up to 18 months after treatment

Secondary Outcomes (6)

• Child anxiety, somatization, and coping

  Four weeks prior to treatment and 6 months after treatment

• Parental somatization, coping, and illness interaction

  Four weeks prior to treatment and 6 months after treatment

• Changes in GI Transit time

  Prior to and after treatment

• Changes in Breath Hydrogen production

  Prior to and after treatment

• Changes in GI Permeability

  Prior to and after treatment

Study Arms (2)

Fiber

EXPERIMENTAL

Fiber added to diet for a total of 6 weeks.

Behavioral: Elimination Diet

Placebo

PLACEBO COMPARATOR

Placebo powder taken for a total of 6 weeks.

Behavioral: Elimination Diet

Interventions

Elimination Diet BEHAVIORAL

Daily diet change for 8 days.

Fiber; Placebo

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (13)

• 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.

  PMID: 17255832 BACKGROUND

• 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.

  PMID: 17222318 BACKGROUND

• 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.

  PMID: 20357915 BACKGROUND

• 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.

  PMID: 12942886 BACKGROUND

• 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.

  PMID: 16581896 BACKGROUND

• 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.

  PMID: 17885479 BACKGROUND

• 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.

  PMID: 18407608 BACKGROUND

• 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.

  PMID: 18052999 BACKGROUND

• McOmber MA, Shulman RJ. Pediatric functional gastrointestinal disorders. Nutr Clin Pract. 2008 Jun-Jul;23(3):268-74. doi: 10.1177/0884533608318671.

  PMID: 18595859 BACKGROUND

• 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.

  PMID: 18538790 BACKGROUND

• 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.

  PMID: 19254999 BACKGROUND

• So SY, Badu S, Wu Q, Yalcinkaya N, Mirabile Y, Castaneda R, Musaad S, Heitkemper M, Savidge TC, Shulman RJ. Sex-Dependent Efficacy of Dietary Fiber in Pediatric Functional Abdominal Pain. Gastroenterology. 2024 Apr;166(4):645-657.e14. doi: 10.1053/j.gastro.2023.12.011. Epub 2023 Dec 19.

  PMID: 38123024 DERIVED

• 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.

  PMID: 27080737 DERIVED

Related Links

• Information about Kids GI Health
• Information about Children in Clinical Research
• Our research group's website at Baylor College of Medicine

MeSH Terms

Conditions

Abdominal Pain; Irritable Bowel Syndrome; Diarrhea; Constipation

Interventions

Elimination Diets

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Robert Shulman

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: September 6, 2007
• First Posted: September 10, 2007
• Study Start: January 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

US (1)