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

Primary Purpose

Irritable Bowel Disease

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Hydro Colon Therapy plus probiotic
Sponsored by
University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Irritable Bowel Disease focused on measuring irritable bowel disease, microbiota, hydro colon therapy, food intolerance

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dep. for Nutritional Sciences, University of Vienna

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hydro Colon Therapy plus probiotic

Arm Description

Hydro Colon therapy including 2-5 washes in 3 weeks, probiotic intervention for 5 weeks after end of hydro Colon therapy

Outcomes

Primary Outcome Measures

microbiota structure, using 16 S ribosomal based gradient electrophoresis ( DGGE)
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
Gastrointestinal comfort, measured by Visual Analog Scale
Gastrointestinal comfort was analysed by a standardised questionnaire. Pain was measured by Visual Analog Scale

Secondary Outcome Measures

Full Information

First Posted
January 12, 2015
Last Updated
February 25, 2015
Sponsor
University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT02372201
Brief Title
Effects of Fasting and Hydro Colon Therapy Plus Probiotics on GI Microbiota in Intolerances and Irritable Bowel Syndrome
Acronym
MicFFGAH2013
Official Title
Effects of Fasting and Hydro Colon Therapy Plus Probiotics on Abundance and Diversity of GI Microbiota in Intolerances and Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Disease
Keywords
irritable bowel disease, microbiota, hydro colon therapy, food intolerance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydro Colon Therapy plus probiotic
Arm Type
Experimental
Arm Description
Hydro Colon therapy including 2-5 washes in 3 weeks, probiotic intervention for 5 weeks after end of hydro Colon therapy
Intervention Type
Other
Intervention Name(s)
Hydro Colon Therapy plus probiotic
Intervention Description
Probiotic intervention was done after 2-5 cycles of hydro colon therapy.
Primary Outcome Measure Information:
Title
microbiota structure, using 16 S ribosomal based gradient electrophoresis ( DGGE)
Description
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
Time Frame
7- 8 weeks hydro colon washes plus probiotic
Title
Gastrointestinal comfort, measured by Visual Analog Scale
Description
Gastrointestinal comfort was analysed by a standardised questionnaire. Pain was measured by Visual Analog Scale
Time Frame
7- 8 weeks hydro colon washes plus probiotic

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Haslberger
Organizational Affiliation
UNIVIE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. for Nutritional Sciences, University of Vienna
City
Vienna
State/Province
Select your state
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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

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