Clinical trial NCT03019861: Ayurvedic Nutritional Counseling for Patients With IBS in Comparison to Conventional Nutritional Counseling
Official title: Randomized Controlled Study on Ayurvedic Nutritional Counseling for Patients With Irritable Bowel Syndrome in Comparison to Conventional Nutritional Counseling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Keywords: Ayurveda
IBS
Complementary medicine
nutritional counseling
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main goal of this randomized controlled clinical study is to evaluate the efficacy of an individual Ayurvedic nutritional counseling (according to tradition) compared to an individual conventional dietary advice (according to the German Nutrition Society - DGE) in patients with irritable bowel syndrome. It is to be investigated whether nutritional therapy elements, which patients can self-implement independently in the home environment, can achieve sustainable therapy effects.


Eligibility criteria: Inclusion Criteria:

* Diagnosis "irritable bowel syndrome" according to the ROM-III criteria and the German S3 guideline (Layer 2011)
* Female and male patients between 18 and 70 years of age
* Declaration of consent

Exclusion Criteria:

* Bad general condition
* Serious acute or chronic comorbidity
* Pregnancy and breast feeding period
* Eating disorder
* In recognition procedures for early retirement or disability
* Simultaneous participation in another clinical trial
* Participation in a clinical trial within the last 3 months before enrollment

Primary outcomes:
measure: Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change
timeFrame: Change from IBS-SSS Baseline at 12 weeks
Secondary outcomes:
measure: Cohen Perceived Stress Scale (CPSS) - Change
timeFrame: Change from CPSS Baseline at 4 weeks, 12 weeks and 6 months
measure: Hospital Anxiety and Depression Scale (HADS-D) - Change
timeFrame: Change from HADS-D Baseline at 4 weeks, 12 weeks and 6 months
measure: Irritable bowel Syndrome - Quality of life (IBS-QOL) - Change
timeFrame: Change from IBS-QOL Baseline at 4 weeks, 12 weeks and 6 months
measure: VAS: Pain, Sleep, General bothersomeness, Expectation - Change
timeFrame: Change from VAS Baseline at 4 weeks, 12 weeks and 6 months
measure: Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change
timeFrame: Change from IBS-SSS Baseline at 4 weeks and 6 months
Other outcomes:
measure: Stool analysis: Intestinal microbiome by sequencing 16S rRNA
timeFrame: Baseline, 4 weeks
measure: Qualitative interviews in focus groups
timeFrame: Baseline, 6 months
Locations:
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
state: Am Deimelsberg 34 A
city: Berlin
country: Germany
facility: Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Study officials:
affiliation: Charité University Medical Center
name: Andreas Michalsen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeitler M, Wottke T, Schumann D, Puerto Valencia LM, Michalsen A, Steckhan N, Mittwede M, Stapelfeldt E, Koppold-Liebscher D, Cramer H, Wischnewsky M, Murthy V, Kessler CS. Ayurvedic vs. Conventional Nutritional Therapy Including Low-FODMAP Diet for Patients With Irritable Bowel Syndrome-A Randomized Controlled Trial. Front Med (Lausanne). 2021 Sep 6;8:622029. doi: 10.3389/fmed.2021.622029. eCollection 2021.