NCT05565612

Brief Summary

The clinical trial has a randomized, double-blind and placebo-controlled design, in which the effect of a probiotic mix wants to be evaluated, with a treatment of 12 weeks, in the evolution of the symptoms of Irritable Bowel Syndrome. The 12 weeks of the treatment are structured in four in-person visits: Visit 1 (initial; week 0), Visit 2 (halfway; week 4), Visit 3 (halfway; week 8) and Visit 4 (final; week 12).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

October 10, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

March 28, 2024

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

September 28, 2022

Last Update Submit

March 27, 2024

Conditions

IBS - Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change from baseline on IBS-SSS (Irritable Bowel Syndrome-Severity Scoring System) scale at 4, 8 and 12 weeks

    IBS index measures the severity of the disease, wich takes into account aspects such as pain, abdominal distension, intestinal habit and quality of life of the patient with IBS Categories of severity according to punctuation on the index IBS-SSS * Mild: 75 \<175 * Moderate: 175 \<300 * Severe: \> 300

    12 weeks

Secondary Outcomes (14)

  • Change from baseline on IBS-QoL (Irritable Bowel Syndrome-Quality of Life) index at 4, 8 and 12 weeks

    12 weeks

  • Change from baseline on values of hemogram to final visit

    12 weeks

  • Change from baseline on values of blood glucose to final visit

    12 weeks

  • Change from baseline on values of blood sodium to final visit

    12 weeks

  • Change from baseline on values of blood potassium to final visit

    12 weeks

  • +9 more secondary outcomes

Other Outcomes (1)

  • Adverse events on weeks 4, 8 and 12

    12 week

Study Arms (2)

Probiotic group

EXPERIMENTAL

Normodigest Classic Multi-strain probiotic mixture (15 strains) with a concentration of 7,5 x 10\^9 + fructooligosaccharides 1 vial of 10 ml per day for 12 weeks

Dietary Supplement: Normodigest Classic

Placebo group

PLACEBO COMPARATOR

Maltodextrin-based placebo 1 vial of 10 ml per day for 12 weeks

Dietary Supplement: Placebo

Interventions

Normodigest ClassicDIETARY_SUPPLEMENT

Symbiotic composed of 15 probiotic strains and fructooligosaccharides as prebiotic

Probiotic group
PlaceboDIETARY_SUPPLEMENT

Compound based on maltodextrin and other excipients

Placebo group

Eligibility Criteria

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

You may qualify if:

  • Aged between 18-65 years old.
  • Informed consent signed by the patient.
  • Patients with Irritable Bowel Syndrome diagnosed by Roma IV criteria

You may not qualify if:

  • Patients who took antibiotics until two weeks prior to study.
  • Patients who have taken other probiotics two months prior.
  • Patients with other intestinal inflammatory diseases.
  • Pregnant, breastfeeding or patients who do not compromise to use an efficient contraceptive method during the development of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MiBioPath UCAM

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Vicente Navarro López, PhD; MD

    Universidad Católica San Antonio de Murcia (UCAM). MiBioPath Group.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pilot randomized, double-blind, placebo-controlled study of a duration of 12 weeks
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 4, 2022

Study Start

October 10, 2022

Primary Completion

December 26, 2023

Study Completion

March 1, 2024

Last Updated

March 28, 2024

Record last verified: 2023-10

Locations

ES(1)