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Completed

NCT Number: NCT02592200

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

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.

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Key information

Conditions

Functional Constipation Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CTC, Akademiska Sjukhuset

Uppsala, 751 85, Sweden

About this study

Subjects to complete study diaries, number of SBM, CSBM, form of faeces (according to the Bristol Stool Form scale), pain during defecation (according to the visual analogue scale [VAS] 0-100), time spent at each evacuation, episodes of faecal incontinence, number of ingested capsules of investigational product will be recorded daily by the subjects

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Lactobacillus gasseri DSM 27123

Dietary Supplement

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

Placebo

Dietary Supplement

Two doses per day for 28 days

Primary outcomes

  1. Change in frequency of complete spontaneous bowel movements (CSBMs)

    Time frame: Baseline and 4 weeks

Secondary outcomes

  1. Change in Stool Consistency (Bristol Stool Form scale)

    Time frame: Baseline, week 1, 2, 3 and 4

    Change in Bristol Stool Form Scale

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

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

    Change in score

  3. Change in Gastrointestinal Symptom Rating Scale (GSRS)

    Time frame: Baseline, week 1, 2, 3 and 4

    Change in Score

  4. Proportion of responders

    Time frame: 4 weeks

    Proportion of responders is defined as subjects showing a mean increase of ≥1 CSBM per week during the treatment period (Day 1 to Day 28) compared to the baseline period (Day-14 to Day -1) or ≥3 CSBMs in the last week of the treatment period (Day 21 to Day 28). The subjects will record time and date of all CSBMs in the study diary.

  5. Number of participants with treatement related adverse events

    Time frame: During the whole study - 4 weeks

    Descriptive

  6. Presence of Lactobacillus gasseri DSM 27123 in faeces

    Time frame: 4 weeks

    qPCR

  7. Need for laxative medication

    Time frame: During the treatment period - 4 weeks

    Time and date of laxative use will be recorded in the study diary by the subjects.

Sponsors and collaborators

Lead sponsor

BioGaia AB

Industry

Registry information

Official study title

A Double Blind Placebo-Controlled Study on the Effect of the Probiotic Lactobacillus Gasseri DSM 27123 on Functional Constipation in Healthy Women - Proof of Concept

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 30, 2015
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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