ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00008729
Date of registration:	29/06/2015
Prospective Registration:	Yes
Primary sponsor:	Postapotheke
Public title:	Influence oft prebiotics and probiotics on gut colonization, weight, lipid profile and blood sugar levels in overweight adults
Scientific title:	Influence oft prebiotics and probiotics on gut colonization, weight, lipid profile and blood sugar levels in overweight adults
Date of first enrolment:	01/07/2015
Target sample size:	30
Recruitment status:	Pending
URL:	http://drks.de/search/en/trial/DRKS00008729
Study type:	interventional
Study design:	Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active//placebo; Assignment: parallel; Study design purpose: prevention
Phase:	N/A

Countries of recruitment
Germany

Contacts

Name:	Michaela Axt-Gadermann
Address:	Friedrich-Streib-Straße 2 96450 Coburg Germany
Telephone:	0661-605860
Email:	michaela.axt-gadermann@hs-coburg.de
Affiliation:	Hochschule Coburg

Name:	Michaela Axt-Gadermann
Address:	Friedrich-Streib-.Str. 2 96450 Coburg Germany
Telephone:	0661-605860
Email:	michaela.axt-gadermann@hs-coburg.de
Affiliation:	Hochschule Coburg

Key inclusion & exclusion criteria

Inclusion criteria: participants: pre-obese (BMI 25 - 29,9) and obese (BMI = 30)
Exclusion criteria: Immunosuppression, inflammatory bowel diseases, pregnancy, therapy with antibiotics

Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

E66.90
E11.90

E11.90

E66.90

Intervention(s)

Group 1: Placebo (identical capsules containing silica) for twelve weeks
Group 2: UK Darmflora, (PZN-00477512)
Inulin, Lactobacillus acidophilus, Lactobazillus rhamnosus, Lactobazillus casei, Bifidobakterium bifidum for twelve weeks

Group 3: Preparation with inulin, pectin, resistant starch, Lactobacillus plantarum, Lactobacillus gasseri, Lactobacillus rhamnosus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium breve for twelve weeks

Primary Outcome(s)

weight loss after 4, 8 and 12 weeks

Secondary Outcome(s)

blood sugar reduction after 4, 8 and 12 weeks

Secondary ID(s)

Source(s) of Monetary Support

Post Apotheke

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 17/06/2015
Contact:

Ethikkommission der Hochschule Coburg [Coburg - Ethikkommission der Hochschule Coburg, Friedrich-Streib-Straße 2, 96450 Coburg]

Results

Results available:
Date Posted:
Date Completed:
URL:	http://drks.de/search/en/trial/DRKS00008729#studyResults

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.