Effect of Lactobacillus Gasseri DSM 27123 on Functional Constipation in Healthy Women

NCT02592200 | Completed

• 1 other identifier: CSUB0092
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to determine the change in frequency of complete spontaneous bowel movements (CSBMs) after 4 weeks of oral supplementation with Lactobacillus gasseri DSM 27123 in healthy adult women with functional constipation.

Conditions

Functional Constipation

Keywords

Female; Constipation; Lactobacillus gasseri DSM 27123; Probiotics

Outcome Measures

Primary Outcomes (1)

• Change in frequency of complete spontaneous bowel movements (CSBMs)

  Baseline and 4 weeks

Secondary Outcomes (7)

• Change in Stool Consistency (Bristol Stool Form scale)

  Baseline, week 1, 2, 3 and 4

• Change in Patient-Assessment of Constipation Symptoms (PAC-SYM)

  Baseline, week 1, 2, 3 and 4 (change from baseline)

• Change in Gastrointestinal Symptom Rating Scale (GSRS)

  Baseline, week 1, 2, 3 and 4

• Proportion of responders

  4 weeks

• Number of participants with treatement related adverse events

  During the whole study - 4 weeks

Study Arms (2)

Lactobacillus gasseri

EXPERIMENTAL

Lactobacillus gasseri DSM 27123 capsules, 1×109 CFU (divided in two doses)

Dietary Supplement: Lactobacillus gasseri DSM 27123

Placebo

PLACEBO COMPARATOR

Placebo capsules (two doses)

Dietary Supplement: Placebo

Interventions

Lactobacillus gasseri DSM 27123 DIETARY_SUPPLEMENT

109 CFU (divided in two doses) per day for 28 days

Lactobacillus gasseri

Placebo DIETARY_SUPPLEMENT

Two doses per day for 28 days

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subjects have to meet all of the following criteria to be eligible to enter the study:
• Willing and able to provide informed consent
• Women aged 18-49 years at Visit 1
• BMI ≥18 and ≤29 at Visit 1
• Suffering of functional constipation as defined by the Rome III criteria for functional constipation
• Comply with the requirement not to use any other probiotic products from Visit 1 and throughout the study period
• Not pregnant or breastfeeding
• Using adequate contraceptive measures
• Ability to understand and comply with the requirements of the study, as judged by the Investigator

You may not qualify if:

• Hypersensitivity or allergy to the investigational product, to chemically related products or to comparator/placebo
• Well-known, organic cause of constipation
• Anorectal pathology
• Previous gastrointestinal surgery
• Any alarming symptoms (i.e. rectal bleeding, weight loss, jaundice) as judged by the Investigator
• Spinal anomalies and injuries
• Use of antibiotics within 4 weeks prior to Visit 1
• Use of products containing probiotics more than once a week in the previous 3 weeks
• Mental or behavioural disorders as judged by the Investigator
• Food allergy

Sponsors & Collaborators

• BioGaia AB: lead

Study Sites (1)

CTC, Akademiska Sjukhuset

Uppsala, 751 85, Sweden

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Per Hellström, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 30, 2015
• Study Start: October 5, 2015
• Primary Completion: June 21, 2016
• Study Completion: July 31, 2016
• Last Updated: January 5, 2021

Record last verified: 2020-12

Locations

SE (1)