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

Irritable Bowel Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372201
• Other study ID #: MicrobColonIrrFFG2013
• Status: Completed
• Phase: N/A
• First received: January 12, 2015
• Last updated: February 25, 2015
• Start date: January 2013
• Est. completion date: October 2014

Study information

• Verified date: February 2015
• Source: University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Intestinal Diseases
• Irritable Bowel Disease
• Irritable Bowel Syndrome

Intervention

Other:
• Hydro Colon Therapy plus probiotic
Probiotic intervention was done after 2-5 cycles of hydro colon therapy.

Locations

Country	Name	City	State
Austria	Dep. for Nutritional Sciences, University of Vienna	Vienna	Select your state

Sponsors (1)

Lead Sponsor	Collaborator
University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7- 8 weeks hydro colon washes plus probiotic	No
Primary	Gastrointestinal comfort, measured by Visual Analog Scale	Gastrointestinal comfort was analysed by a standardised questionnaire. Pain was measured by Visual Analog Scale	7- 8 weeks hydro colon washes plus probiotic	No