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Completed

NCT Number: NCT04437147

Effect of Probiotics on Functional Constipation in Adults

Introduction:

Functional constipation is a symptom-based gastrointestinal disorder without an organic origin (eg, bowel obstruction). It has a prevalence of 14% in adults.

Objective:

The objective of trial is to evaluate the efficacy and safety of two different probiotic blends in adults subjects with functional constipation.

Methods:

A double-blind, randomized, placebo-controlled study will be conducted for up to two years to evaluate the efficacy of two different probiotic mixtures: (Mixture 1) Lactobacillus acidophilus, Bifidobacterium bifidum and Lactobacillus rhamnosus (3 billion CFU); (Mixture 2) Lactobacillus acidophilus, Bifidobacterium bifidum, Lactobacillus rhamnosus, Lactobacillus paracasei, Bifidobacterium longum, Bifidobacterium lactis, Lactobacillus defensis, Bifidobacterium animallis (8 billion CFU).

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Key information

Conditions

Functional Constipation

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade de Sorocaba

Sorocaba, São Paulo, 19023000, Brazil

About this study

The study involve 150 healthy volunteers with functional constipation.The sample size was based on literature reviews of the probiotics' effect comparing the differences between means.

After confirmation of eligibility and obtaining written informed consent, the patients will be randomized (stratification for blocks) to recivied the interventions. The patients and the phisician will be blinded to the treatment received. The eligible patients will be allocated (1:1:1) to treatment with either the probiotics supplements or placebo. Subjects will be instructed to ingest one sachet before breakfast, by mixing the powder in water and drinking it. The sachets will be stored at room temperature.

Data handling and record keeping Case report forms will be used to record data for all participants, and will be completed by the research doctor, who will also enter the data into an electronic database.

Study schedule and location After inclusion, all further treatments will be managed at the primary care center where the subject was recruited. A research doctor and a research pharmacist will be responsible for all contacts with patients.

Local of study development Recruitment of patients to this study will be made by collaboration with the Gastroenterolgy Clinic at Avenue Dr Armando Sales de Oliveira 371, Trujilo, Sorocaba, State of São Paulo, Brazil from March 2020 to April 2020. Sorocaba is a Brazilian municipality in the interior of the state of São Paulo. It is the fourth most populous in the interior of São Paulo in the Southeast of the country, and the most populous in the southern region of São Paulo, with a population of 671,186 inhabitants, estimated by IBGE for July 1, 2018.

For comparison of three groups, an independent t-test will be applied for continuous variables and Mann-Whitney for non-continuous variables. Analysis of adverse events (if any) will be performed using Chi-Square test and Fisher's exact test following assumptions of randomness, independence and size. Significance differences will be set at p<0.05.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

-Clinical diagnosis of functional constipation according to Rome IV. Granting of written informed consent.

Exclusion criteria

  • Presence of gastrointestinal diseases
  • Ingestion of antibiotics or dietary supplements containing probiotics or prebiotics in the last 15 days
  • Pregnancy.

Treatment and study plan

Placebo

Dietary Supplement

Fibers with vitamins and minerals will be administered for 30 days once a day in sachets

Other names: Group Placebo

3 Billion UFC strains of probiotics

Dietary Supplement

Fibers with vitamins and minerals will be administered for 30 days once a day in sachets with 3 billion CFU strains of probiotics

8 Billion UFC strains of probiotics

Dietary Supplement

Fibers with vitamins and minerals will be administered for 30 days once a day in sachets with 8 billion CFU strains of probiotics

Primary outcomes

  1. Changed in the number of Bowel movements. Changed for more than 3 per week was considered a clinical response.

    Time frame: 30 days

    Changed number of bowel movements evaluated weekly

  2. Change in the Bristol stool form scale at 4 weeks after Probiotics. Recovery to types 3-4 was considered a clinical response.

    Time frame: 30 days

    The Bristol scale ranges from 1-7, with 1-2 being constipated, 3-5 normal and 6-7 diarrhea.

Secondary outcomes

  1. Subject withdrawal

    Time frame: 30 days

    The volunteers can withdraw from the study at any time by their own request, or can be withdrawn at any time at the discretion of the investigator for safety. Volunteers will also be withdrawn from the study in the event of treatment interruption for any reason, whether due to forgetfulness or to experiencing undue intestinal discomfort

  2. Adverse events

    Time frame: 30 days

    Adverse events are undesirable signs or symptoms that occur during the study and whose cause may or may not be causal related to the treatment. All adverse events considered possibly, probably or related to the test product will be noted down on the patient's form.

  3. Serious adverse events

    Time frame: 30 days

    Serious adverse events are defined as events that are fatal, life-threatening, disabling or result in hospitalization or prolonged stay, or result in malformation, whether related to the test product or otherwise.

    According to previous studies, probiotics are safe and any serious adverse event that could possibly, probably or be related to the test products will be considered unexpected. All unexpected serious adverse events will be reported to the physician. Any serious adverse event that may be related to the test product will immediately lead to discontinuation of the test product

Sponsors and collaborators

Lead sponsor

Luciane Cruz Lopes

Other

Registry information

Official study title

The Effect of Probiotics on Functional Constipation in Adults: Double-blind, Randomized, Placebo-controlled Study

Acronym: PROBCON

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 18, 2020
Registry last updated
Jan 29, 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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