NCT03019861

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

1.7 years

First QC Date

January 2, 2017

Last Update Submit

August 2, 2021

Conditions

IBS - Irritable Bowel Syndrome

Keywords

AyurvedaIBSComplementary medicinenutritional counseling

Outcome Measures

Primary Outcomes (1)

  • Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change

    Change from IBS-SSS Baseline at 12 weeks

Secondary Outcomes (5)

  • Cohen Perceived Stress Scale (CPSS) - Change

    Change from CPSS Baseline at 4 weeks, 12 weeks and 6 months

  • Hospital Anxiety and Depression Scale (HADS-D) - Change

    Change from HADS-D Baseline at 4 weeks, 12 weeks and 6 months

  • Irritable bowel Syndrome - Quality of life (IBS-QOL) - Change

    Change from IBS-QOL Baseline at 4 weeks, 12 weeks and 6 months

  • VAS: Pain, Sleep, General bothersomeness, Expectation - Change

    Change from VAS Baseline at 4 weeks, 12 weeks and 6 months

  • Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change

    Change from IBS-SSS Baseline at 4 weeks and 6 months

Other Outcomes (2)

  • Stool analysis: Intestinal microbiome by sequencing 16S rRNA

    Baseline, 4 weeks

  • Qualitative interviews in focus groups

    Baseline, 6 months

Study Arms (2)

Ayurvedic nutritional counseling

ACTIVE COMPARATOR

Patients will receive three Ayurvedic nutritional counselings (according to tradition) after 1, 3 and 8 weeks after Baseline.

Behavioral: Ayurvedic nutritional counseling

Conventional nutritional counseling

ACTIVE COMPARATOR

Patients will receive three conventional nutritional counselings (according to German Nutrition Society - DGE) after 1, 3 and 8 weeks after Baseline.

Behavioral: Conventional nutritional counseling

Interventions

Ayurvedic nutritional counselingBEHAVIORAL
Ayurvedic nutritional counseling
Conventional nutritional counselingBEHAVIORAL
Conventional nutritional counseling

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kliniken Essen-Mitte

Essen, Am Deimelsberg 34 A, 45276, Germany

Location

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Berlin, 14109, Germany

Location

Related Publications (1)

  • 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.

    PMID: 34552937DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Andreas Michalsen, Prof. Dr.

    Charité University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 2, 2017

First Posted

January 13, 2017

Study Start

January 1, 2017

Primary Completion

October 1, 2018

Study Completion

February 1, 2019

Last Updated

August 6, 2021

Record last verified: 2021-08

Locations

DE(2)