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Effect of Probiotic Mixture Supplementation on Constipation

Effect of Probiotic Mix Therapy on Intestinal Constipation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9gzqp3v
Enrollment
Unknown
Registered
2024-10-31
Start date
2020-10-19
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal constipation

Interventions

A double-blind, randomized, placebo-controlled clinical trial with a four-week intervention period was carried out over four weeks. Women aged 20 to 59 years, diagnosed with functional constipation, w
G07.203.300.456.500

Sponsors

Faculdade de Nutrição - Universidade Federal de Goiás
Lead Sponsor
Faculdade de Nutrição - Universidade Federal de Goiás
Collaborator

Eligibility

Sex/Gender
Female
Age
20 Years to 59 Years

Inclusion criteria

Inclusion criteria: Women; age between 20 and 59; self-reported stool types two to four on the Bristol Stool Scale; who had at least two of the criteria on the Rome IV Index

Exclusion criteria

Exclusion criteria: Women undergoing bariatric surgery; history of persistent diarrhea or inflammatory bowel disease; irritable bowel syndrome; vegetarian or on a diet; regular alcohol consumption (> 7 drinks/week); smokers; moderate or vigorous exercise > 3 h/week; use of antibiotics, laxatives, immunosuppressants, diuretics and antacids within one month before the start of the intervention; use of probiotic, prebiotic or symbiotic supplements; use of fermented foods during this same period

Design outcomes

Primary

MeasureTime frame
We expect to observe at least a 10% increase in evacuation frequency, as assessed by the ROMA IV questionnaire, after the intervention with the probiotic mix compared to the placebo group.;After four weeks of probiotic supplementation, 63.16% of individuals in the intervention group experienced a reversal of constipation, compared to 36.36% in the placebo group

Secondary

MeasureTime frame
Severe constipation (Bristol scale type 1) was extinguished in the probiotic group, whereas it persisted in 27.3% of the placebo group ;The placebo group exhibited significantly lower microbial diversity compared to the probiotic group at the end of intervention

Countries

Brazil

Contacts

Public ContactJoão Mota

Universidade Federal de Goiás

jfemota@gmail.com+55(62)32096270

Outcome results

None listed

Source: REBEC (via WHO ICTRP)