Effects of Fasting and Hydro Colon Therapy Plus Probiotics on GI Microbiota in Intolerances and Irritable Bowel Syndrome (MicFFGAH2013)

February 25, 2015 updated by: Univ. Doz. Dr. Alexander Haslberger, University of Vienna

Effects of Fasting and Hydro Colon Therapy Plus Probiotics on Abundance and Diversity of GI Microbiota in Intolerances and Irritable Bowel Syndrome

Consequences of Colon Hydrotherapy plus probiotic intervention on composition of GI microbiota and well being are analysed in subjects claiming GI inconveniences due to Irritable Bowel Syndrome or food intolerances.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study objectives: Analysis of consequences of Hydro Colon Therapy plus probiotic intervention on GI microbiota and well being.

Study group: 78 subjects, inclusion criteria: 20-50yrs; under consultation at doctors or nutritionists because of claimed food inconveniences or Irritable Bowel Syndrome. exclusion criteria: antibiotics treatment and specified complex diseases.

Intervention: Hydro colon therapy 2- 5 washes within 3 weeks. probiotic intervention after end of Hydro colon therapy for 6 weeks ( DUOLAC® bacterial strains per capsule: Lactobacillus plantarum, Streptococcus thermophiles, Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis, Bifidobacterium longum, and Bifidobacterium breve, fructooligosaccharides, 200 µg folic acid, 2.50 µg vitamin B12 and 55 µg selenium (all amounts corresponding to 100% of daily requirement). Control group: Vitamin B complex: 10µg cobalamin, 450µg folic acid, and 55 µg selenium.

Sample collection: standardized Feces collection, T1, before colon hydrotherapy, T2, immediately after colon hydrotherapy 2-5 washes of fasting ; T3, after six weeks of probiotic or Control intervention Analysis: standardizes food frequency questionnaire before and after intervention.

Feces analysis based on 16 S ribosomal DNA (rDNA) PCR DGGE and quantitative PCR (qPCR) and bioinformatic analysis.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Select your state
      • Vienna, Select your state, Austria, 1090
        • Dep. for Nutritional Sciences, University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects under consultation at doctors or nutritionists for Inflammatory Bowel Syndrome (IBD) of food intolerances

Exclusion Criteria:

  • Pregnancy
  • Antibiotic therapy 0,5 yrs before start
  • Hormone therapies
  • Malignant diseases
  • Subjects were asked to avoid dietary supplements 4 weeks before and during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydro Colon Therapy plus probiotic
Hydro Colon therapy including 2-5 washes in 3 weeks, probiotic intervention for 5 weeks after end of hydro Colon therapy
Other: Hydro Colon Therapy plus probiotic
Probiotic intervention was done after 2-5 cycles of hydro colon therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
microbiota structure, using 16 S ribosomal based gradient electrophoresis ( DGGE)
Time Frame: 7- 8 weeks hydro colon washes plus probiotic
Microbiota were analysed for abundance of main microbiota groups and microbiota diversity using 16 S ribosomal based gradient electrophoresis ( DGGE). Abundance is shown in DNA copies/g feces; diversity as number of bands/ sample and by bioinformatic analysis
7- 8 weeks hydro colon washes plus probiotic
Gastrointestinal comfort, measured by Visual Analog Scale
Time Frame: 7- 8 weeks hydro colon washes plus probiotic
Gastrointestinal comfort was analysed by a standardised questionnaire. Pain was measured by Visual Analog Scale
7- 8 weeks hydro colon washes plus probiotic

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vienna

Investigators

  • Principal Investigator: Alexander Haslberger, UNIVIE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

February 25, 2015

First Posted (Estimate)

February 26, 2015

Study Record Updates

Last Update Posted (Estimate)

February 26, 2015

Last Update Submitted That Met QC Criteria

February 25, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MicrobColonIrrFFG2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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