MedTrace Logo

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

NCT02613078 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-03-03

No results posted yet for this study

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

Interventions

BEHAVIORAL

Gut-Directed Hypnotherapy

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

DIETARY_SUPPLEMENT

Nutritional 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

BEHAVIORAL

Self-Monitoring

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)

Sponsors & Collaborators

  • SymbioPharm GmbH

    collaborator INDUSTRY

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Marco D Gulewitsch, PhD · Eberhard Karls University, Tübingen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-04-30
Completion
2017-10-31

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02613078 on ClinicalTrials.gov