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

NCT02372201 | Completed

• 1 other identifier: MicrobColonIrrFFG2013
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Disease

Keywords

irritable bowel disease; microbiota; hydro colon therapy; food intolerance

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Hydro Colon Therapy plus probiotic

EXPERIMENTAL

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

Interventions

Hydro Colon Therapy plus probiotic OTHER

Probiotic intervention was done after 2-5 cycles of hydro colon therapy.

Hydro Colon Therapy plus probiotic

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Vienna: lead

Study Sites (1)

Dep. for Nutritional Sciences, University of Vienna

Vienna, Select Your State, 1090, Austria

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Food Intolerance

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Alexander Haslberger

  UNIVIE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ. Dozent

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: February 26, 2015
• Study Start: January 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 26, 2015

Record last verified: 2015-02

Locations

AU (1)