Clinical study carried out to investigate the efficacy of two probiotic formulates on irritable bowel syndrome

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN15032219
• Date of registration: 19/04/2016
• Prospective Registration: No
• Primary sponsor: Farcoderm S.R.L.
• Public title: Clinical study carried out to investigate the efficacy of two probiotic formulates on irritable bowel syndrome
• Scientific title: Effects of multispecies probiotic supplementation on irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial
• Date of first enrolment: 01/09/2013
• Target sample size: 150
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN15032219
• Study type: Interventional
• Study design: Randomized double-blind three-arm placebo-controlled trial (Treatment)

Countries of recruitment

Italy

Contacts

• Name: Angela Michelotti

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Irritable bowel syndrome associated constipation (IBS-C)
Digestive System
Irritable bowel syndrome associated constipation (IBS-C)

Intervention(s)

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.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

MI.02.DS.L_2013/PROBIOPLUS 4 FOOD

Source(s) of Monetary Support

Ministero dell’Istruzione, dell’Università e della Ricerca