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Intestinal Bacteria Flora Disturbance
+1

Effects of Probiotic on Modulation of the Intestinal Microbiota in Constipated Patients

Sponsored by Farmoquimica S.A.

About this trial

Last updated 8 years ago

Study ID

FE4-PROBIATOP-PA-14

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Yes

Accepting

18-75 Years
18 to 55 Years
All
All

Trial Timing

Ended 9 years ago

What is this trial about?

The probiotic for oral use, Probiatop®, consists of Lactobacillus acidophilus NCFM, Lactobacillus rhamnosus HN001, Lactobacillus paracasei LPC-37 and Bifidobacterium lactis HN019. Its activity will be compared with placebo (Maltodextrin). The metagenomics data will be correlated with the Quality of Life Questionnaire answers obtained from participants with intestinal transit problem. The Increase in the number of evacuations, as well as the improvement of complaints related to intestinal transit alteration will be evaluated during the study. The participants will use probiotic or placebo for a period of 28 days and the gastrointestinal function questionnaire and collect stool will be performed before the study and after period of treatment

What are the participation requirements?

Yes

Inclusion Criteria

- Agree to adhere to the procedures and requirements of the study and attend the institute on the day (s) and time (s) determined for the evaluations;

- Being able to consent study participation

- Have one or more complaints of change in bowel habits in the last 3 months with onset of symptoms at least 6 months before diagnosis, as described below:

- Evacuation effort for at least 25% of defecations
- Lumpy stools, on sausage-shaped or hardened in at least 25% of stools, according to the Bristol scale. number 1, 2 or 3;
- Incomplete evacuation count in at least 25% of defecations;
- Feeling of anorectal obstruction / blockage of feces in at least 25% of defecations;
- Manufactured manuals to facilitate at least 25% of stools (for example, evacuation with digital help, pelvic floor support)
No

Exclusion Criteria

- Pregnancy or breast-feeding;

- Known intolerance or allergy to any of the study products;

- Previous history of gastrointestinal surgery;

- Patients with celiac disease or inflammatory bowel disease;

- Patients with psychiatric, cardiologic, respiratory, renal and hepatic disease;

- No acceptance of study admission by the participant; Diagnosis of Clostridium difficile diarrhea in the last 3 months;

- Patients with known immunosuppressive disease;

- Any other gastrointestinal pathology;

- Prior use of antibiotics in less than 30 days;

- Frequent use of laxatives or other medication that alters bowel motility (one week without Use before inclusion)

- Regular treatment with probiotics / symbiotic, including regular use of yogurt with probiotics (One week before use before inclusion)

- Regular use of antidepressant, opioid analgesic, antispasmodic or anticholinergic agents