Condition category
Digestive System
Date applied
18/04/2016
Date assigned
19/04/2016
Last edited
07/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Irritable bowel syndrome (IBS) is a common, long-term disorder of the digestive system. It is part of a group of disorders called functional bowel disorders, as it affects the way the bowel (intestines) functions. IBS is associated with a number of digestive symptoms such as abdominal pain, diarrhoea, constipation and flatulence, which vary from person to person. The use of probiotics (live bacteria that are good for health as they replenish “good” bacteria that help the digestive system to work properly) has been shown to have beneficial effects on the health of people with IBS. The aim of this study is to compare two different probiotic mixtures in their effectiveness at treating irritable bowel syndrome with constipation (IBS-C).

Who can participate?
Adults with IBS-C.

What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group take capsules containing the first probiotic mix, which contains the bacteria Lactobacillus acidophilus and Lactobacillus reuteri, once a day for 60 days. Those in the second group group take capsules containing the first probiotic mix, which contains the bacteria Lactobacillus plantarum, Lactobacillus rhamnosus and Bifidobacterium animalis subspecies lactis, once a day for 60 days. Those in the third group take capsules containing a placebo (dummy) once a day for 60 days. All participants provide stool samples at the start of the study and then again after 10, 30, 60 and 90 days in order to measure the composition of the bacteria in the gut. At the same times, participants also complete a questionnaire about the IBS-C related symptoms they are having.

What are the possible benefits and risks of participating?
Participants who take the probiotic mixtures may benefit from an improvement to their IBS symptoms. There are no notable risks involved with taking part in this study.

Where is the study run from?
Farcoderm Clinic (Italy)

When is the study starting and how long is it expected to run for?
July 2013 to January 2015

Who is funding the study?
Ministry of Education, Universities and Research (Italy)

Who is the main contact?
Dr Anela Michelotti

Trial website

Contact information

Type

Scientific

Primary contact

Dr Angela Michelotti

ORCID ID

Contact details

Farcoderm S.R.L.
Via Mons. Angelini
21
San Martino Siccomario
27028
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MI.02.DS.L_2013/PROBIOPLUS 4 FOOD

Study information

Scientific title

Effects of multispecies probiotic supplementation on irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial

Acronym

Study hypothesis

The aim of this study is to compare the clinical efficacy of two multispecies probiotic formulates, in particular their beneficial role in the functional bowel disorders will be state in comparison with a placebo.

Ethics approval

Independent Ethical Committee for Non-Pharmacological Clinical studies, 17/07/2013

Study design

Randomized double-blind three-arm placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Irritable bowel syndrome associated constipation (IBS-C)

Intervention

For the study 150 adult subjects, diagnosed with irritable bowel syndrome associated to constipation (IBS-C) were enrolled and divided in three groups (F_1, F_2, F_3). Each group received a daily oral administration of different probiotic mixtures (for a total period of 60 days). Participants are randomly allocated to one of three groups:

Group 1: Participants receive probiotics mix F_1 (Lactobacillus acidophilus and Lactobacillus reuteri) capsules to take once daily for 60 days.
Group 2: Participants receive probiotics mix F_2 (Lactobacillus plantarum, Lactobacillus rhamnosus and Bifidobacterium animalis subsp. lactis) capsules to take once daily for 60 days.
Group 3: Participants receive a placebo in the form of mix F_3 capsules to take once daily for 60 days.

Participants in all groups are followed for a further period of 30 days after a follow-up period from the last
ingestion of the tested products; during this period they doesn’t take anything.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

1. IBS-C symptoms are measured using the IBS-C questionnaire of related symptoms, which consists of five items (bloating, abdominal pain, constipation, abdominal cramps and flatulence) scored on a 10-point Visual Analogue Scale (VAS) at baseline, 10, 30 and 60 days
2. Gut colonization is determined through fecal microbiological analyses using species-specific qPCR on stool samples collected at baseline, 10, 30 and 60 days

Secondary outcome measures

Maintenance of the obtained effects are measured using IBS-C symptoms questionnaire microbiological analyses performed by species-specific qPCR 30 days after the last product(s) intake.

Overall trial start date

05/07/2013

Overall trial end date

30/01/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 18 and 65 years old
2. Suffering from Irritable Bowel Syndrome with constipation (IBS-C)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Pregnancy or intention to become pregnant during the study period
2. Lactation
3. Food intolerances/allergy
4. Known history of gastro-intestinal disorders
5. Chronic or acute gastrointestinal disorders
6. Participation in another similar study
7. Unwillingness or inability to comply with the study protocol requirements
8. Currently using food supplements or drugs containing actives having an influence on gastro-intestinal physiology

Recruitment start date

01/09/2013

Recruitment end date

01/10/2014

Locations

Countries of recruitment

Italy

Trial participating centre

Farcoderm Clinic (Farcoderm Poliambulatorio)
Via Mons. Angelini, 21
San Martino Siccomario (PV)
27028
Italy

Sponsor information

Organisation

Farcoderm S.R.L.

Sponsor details

Via Mons. Angelini
21
San Martino Siccomario
27028
Italy

Sponsor type

Other

Website

Funders

Funder type

Government

Funder name

Ministero dell’Istruzione, dell’Università e della Ricerca

Alternative name(s)

Ministry of Education, University and Research, Ministry of Education, Universities and Research, MIUR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Italy

Results and Publications

Publication and dissemination plan

Planned publication in BioMed Research International (Hindawi Publishing Corporation).

Intention to publish date

31/05/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27595104

Publication citations

Additional files

Editorial Notes

07/09/2016: Publication reference added.