NCT05980988

Brief Summary

To evaluate the effectiveness and safety of the use of probiotics as food supplements in regulating the intestinal habit of subjects with chronic constipation, in comparison with placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
Last Updated

August 8, 2023

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

July 28, 2023

Last Update Submit

August 7, 2023

Conditions

Chronic Constipation

Keywords

Probiotics；Chronic constipation

Outcome Measures

Primary Outcomes (1)

  • changes in fecal state

    use Bristol Scale to record the type of fecal state

    84 days

Study Arms (2)

Probiotic group

EXPERIMENTAL

2B CFU/capsule/day BLa80, before meals； Storage: Store in a cool, dry place without sun exposure.

Dietary Supplement: Probiotic

placebo

PLACEBO COMPARATOR

Maltodextrin, one capsule/day, before meals； Storage: Store in a cool, dry place without exposure to the sun.

Dietary Supplement: Placebo

Interventions

ProbioticDIETARY_SUPPLEMENT

The experimental phase of this study had last 84 days, and each patient will make 4 visits (d1, d28, d56, d84).

Probiotic group
PlaceboDIETARY_SUPPLEMENT

Placebo

placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic constipation (duration more than 3 months with less than three bowel movements per week and/or Bristol Scale 1 and 2).

You may not qualify if:

  • Diabetic patients.
  • Pregnant patients.
  • Breastfeeding patients.
  • Patients requiring antibiotic treatment.
  • Patients requiring treatment with tricyclic antidepressants, antiepileptics, antihistamines, antiparkinsonians, antipsychotics, antispasmodics, verapamil, monoamine oxidase inhibitors, opiates, sympathomimetics, antacids (with aluminum and calcium), antidiarrheals and nonsteroidal anti-inflammatory drugs.
  • Patients who change the type of diet during the study.
  • Patients with allergy or intolerance to any of the ingredients in the formulation of the product under study.
  • Subjects with a history of pharmacological, alcoholic, or other substance abuse, or other factors that limit their ability to cooperate during the study.
  • Excessive alcohol consumption (\>3 glasses of wine or beer/day).
  • Subjects whose condition does not make them eligible for the study, according to the researcher.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CAP Can Bou Castelldefels and CAP Corbera de Llobregat

Barcelona, Spain

Location

Family and Community Medicine CAP Roger

Barcelona, Spain

Location

Related Publications (1)

  • Salo E, Roche D, Gomez-Martinez VB, Cruz-Domenech JM, Garcia-Mora LG, Gabernet-Castello C, Freixenet N. Bifidobacterium animalis subsp. lactis BLa80 regulates the intestinal habit in adults with chronic constipation: a multicentre, randomised, double-blind, placebo-controlled study. Benef Microbes. 2024 Sep 5;15(6):679-688. doi: 10.1163/18762891-bja00038.

    PMID: 39244201DERIVED

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • METHODEX SL

    Methodex

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Double（Participant, Investigator)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2023

First Posted

August 8, 2023

Study Start

September 9, 2021

Primary Completion

February 2, 2023

Study Completion

April 6, 2023

Last Updated

August 8, 2023

Record last verified: 2023-07

Locations

ES(2)