Hypnotherapy vs. Probiotics in Children With IBS and Functional Abdominal Pain

NCT02613078 | Unknown

• 1 other identifier: MDG 082015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Current study aims to investigate the influence of gut-directed hypnotherapy and probiotic nutritional supplement (SymbioLact B) on gastrointestinal symptoms in children with functional abdominal pain or irritable bowel syndrome compared to self-observation only. The study also includes collection of psychometric data (emotional and behavioral problems, pain coping strategies), data on activity of the autonomous nerve system as measured by heart rate variability and data on stress response (saliva cortisol levels).

Conditions

Irritable Bowel Syndrome; Functional Abdominal Pain Syndrome

Keywords

Children; Functional Abdominal Pain Syndrome; Irritable Bowel Syndrome; Gut-Directed Hypnotherapy; Probiotic

Outcome Measures

Primary Outcomes (1)

• Change in number of days with pain/discomfort

  baseline, at week 10 and at 3 months follow-up

Secondary Outcomes (10)

• Change in parental report on gastrointestinal symptoms (Abdominal Pain Index (API))

  baseline, at week 10 and at 3 months follow-up

• Change in pain related disability (Pediatric Pain Disability Index (P-PDI))

  baseline, at week 10 and at 3 months follow-up

• Change in somatic complaints (Children's Somatization Inventory (CSI))

  baseline, at week 10 and at 3 months follow-up

• Change in health-related quality of life (KINDL-R Questionnaire)

  baseline, at week 10 and at 3 months follow-up

• Change in pain-related coping (Pediatric Pain Coping Inventory (PPCI))

  baseline, at week 10 and at 3 months follow-up

Study Arms (3)

Gut-Directed Hypnotherapy (GDH)

EXPERIMENTAL

Gut-Directed Hypnotherapy on a daily basis (20 min each day, at least 4 times/week)

Behavioral: Gut-Directed Hypnotherapy; Behavioral: Self-Monitoring

Probiotic (NS)

EXPERIMENTAL

Nutritional supplement SymbioLact B once a day diluted in water or tea

Dietary Supplement: Nutritional Supplement; Behavioral: Self-Monitoring

Active Controls (AC)

ACTIVE COMPARATOR

AC group keeps a symptom dairy (self-monitoring)

Behavioral: Self-Monitoring

Interventions

Gut-Directed Hypnotherapy BEHAVIORAL

Hypnotherapy protocol is based on the Manchester protocol for gut-directed hypnotherapy and was adapted for children and adolescents. It consists of elements aiming at relaxation and suggestions for control and relief from pain and discomfort. The hypnotherapy will be provided using a CD. Children of the hypnotherapy condition will be instructed to practice with their CD on a daily basis (20 min each day, at least 4 times/week) during 4 weeks

Gut-Directed Hypnotherapy (GDH)

Nutritional Supplement DIETARY_SUPPLEMENT

SymbioLact® B a preparation of Bifidobacterium lactis and vitamin B7, Biotin. Number of living organisms in one dose is at least 1 x 10\^9 cfu. SymbioLact® B will be used in the dose recommended in the pediatric patient information sheet - one dose of SymbioLact® B diluted in water or tee once a day together with a main meal during 4 weeks

Also known as: SymbioLact B

Probiotic (NS)

Self-Monitoring BEHAVIORAL

Use of symptom diary that questions about main bowel complains (including pain or discomfort) during the day. Applied on a daily basis (about 2 min in the evening)

Active Controls (AC); Gut-Directed Hypnotherapy (GDH); Probiotic (NS)

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age between 6 and 17
• participants should fulfill following criteria for functional abdominal pain (FAP) or irritable bowel syndrome (IBS) according to Rome III Consensus
• medical report from a gastroenterologist about absence of an organic reason for the gastrointestinal complaints

You may not qualify if:

• organic reason for abdominal pain is diagnosed (e.g. celiac disease, inflammable bowel diseases)
• children fulfill criteria for abdominal migraine
• other acute or chronic disorders of the gastrointestinal, cardiovascular or peripheral nervous system are present
• inability to follow instructions

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• SymbioPharm GmbH: collaborator

Study Sites (1)

University Clinic

Tübingen, 72076, Germany

RECRUITING

Related Publications (10)

• Chitkara DK, Rawat DJ, Talley NJ. The epidemiology of childhood recurrent abdominal pain in Western countries: a systematic review. Am J Gastroenterol. 2005 Aug;100(8):1868-75. doi: 10.1111/j.1572-0241.2005.41893.x.

  PMID: 16086724 BACKGROUND

• Schlarb AA, Gulewitsch MD, Bock Genannt Kasten I, Enck P, Hautzinger M. Recurrent abdominal pain in children and adolescents - a survey among paediatricians. Psychosoc Med. 2011 Mar 28;8:Doc02. doi: 10.3205/psm000071.

  PMID: 21468324 BACKGROUND

• Chitkara DK, van Tilburg MA, Blois-Martin N, Whitehead WE. Early life risk factors that contribute to irritable bowel syndrome in adults: a systematic review. Am J Gastroenterol. 2008 Mar;103(3):765-74; quiz 775. doi: 10.1111/j.1572-0241.2007.01722.x. Epub 2008 Jan 2.

  PMID: 18177446 BACKGROUND

• Campo JV, Di Lorenzo C, Chiappetta L, Bridge J, Colborn DK, Gartner JC Jr, Gaffney P, Kocoshis S, Brent D. Adult outcomes of pediatric recurrent abdominal pain: do they just grow out of it? Pediatrics. 2001 Jul;108(1):E1. doi: 10.1542/peds.108.1.e1.

  PMID: 11433080 BACKGROUND

• Tack J, Fried M, Houghton LA, Spicak J, Fisher G. Systematic review: the efficacy of treatments for irritable bowel syndrome--a European perspective. Aliment Pharmacol Ther. 2006 Jul 15;24(2):183-205. doi: 10.1111/j.1365-2036.2006.02938.x.

  PMID: 16842448 BACKGROUND

• Sandhu BK, Paul SP. Irritable bowel syndrome in children: pathogenesis, diagnosis and evidence-based treatment. World J Gastroenterol. 2014 May 28;20(20):6013-23. doi: 10.3748/wjg.v20.i20.6013.

  PMID: 24876724 BACKGROUND

• Korterink JJ, Ockeloen L, Benninga MA, Tabbers MM, Hilbink M, Deckers-Kocken JM. Probiotics for childhood functional gastrointestinal disorders: a systematic review and meta-analysis. Acta Paediatr. 2014 Apr;103(4):365-72. doi: 10.1111/apa.12513. Epub 2014 Jan 7.

  PMID: 24236577 BACKGROUND

• Tabbers MM, Chmielewska A, Roseboom MG, Crastes N, Perrin C, Reitsma JB, Norbruis O, Szajewska H, Benninga MA. Fermented milk containing Bifidobacterium lactis DN-173 010 in childhood constipation: a randomized, double-blind, controlled trial. Pediatrics. 2011 Jun;127(6):e1392-9. doi: 10.1542/peds.2010-2590. Epub 2011 May 23.

  PMID: 21606153 BACKGROUND

• Banaszkiewicz A, Szajewska H. Ineffectiveness of Lactobacillus GG as an adjunct to lactulose for the treatment of constipation in children: a double-blind, placebo-controlled randomized trial. J Pediatr. 2005 Mar;146(3):364-9. doi: 10.1016/j.jpeds.2004.10.022.

  PMID: 15756221 BACKGROUND

• Gulewitsch MD, Muller J, Hautzinger M, Schlarb AA. Brief hypnotherapeutic-behavioral intervention for functional abdominal pain and irritable bowel syndrome in childhood: a randomized controlled trial. Eur J Pediatr. 2013 Aug;172(8):1043-51. doi: 10.1007/s00431-013-1990-y. Epub 2013 Apr 9.

  PMID: 23568514 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Dietary Supplements; Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Officials

• Marco D Gulewitsch, PhD

  Eberhard Karls University, Tübingen, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco D Gulewitsch, PhD

CONTACT

+4970712977187; marco-daniel.gulewitsch@uni-tuebingen.de

Paul Enck, PhD

CONTACT

+4970712989118; paul.enck@uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: November 24, 2015
• Study Start: March 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 3, 2016

Record last verified: 2016-02

Locations

DE (1)