Intestinal Bacteria Flora DisturbanceNCT03103958
Effects of Probiotic on Modulation of the Intestinal Microbiota in Constipated Patients
A study testing Probiotic in people with Intestinal Bacteria Flora Disturbance and Constipation, run by Farmoquimica S.A..
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Bacteria Flora Disturbance, Constipation
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 28 Jun 2016to 6 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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;
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- 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
About this study
Official title: Phase IV, Double Blind, Randomized, Study Between Probiatop and Placebo for the Assessment of Improving the Gastrointestinal Function and Intestinal Bacterial Flora in Constipated Patients
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
Read the detailed description
It is a double-blind, randomized, placebo control study that evaluated the action of a probiotic in relation to a placebo in the human intestinal microbiome by the technique of metagenomics, as well as evaluated the effects of this probiotic on the gastrointestinal transit of constipated participants.
One hundred and twenty constipated patients will be randomized into two groups:Probiatop or Placebo. The first 22 patients from each group will also perform a metagenomic evaluation through the stool sample collection before and after of treatment. Besides these procedures, all patients will fill out a symptom assessment questionnaire at baseline of the study, and then after 14 and 28 days after the beginning of the treatment.
- Being tested
- Probiotic, Placebo
- Keywords
- probiotic, metagenomic, constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Also called Probiatop
Probiatop is a live microbial preparation saches containing 1g of the formulation composed by Lactobacillus acidophilus NCFM, 10⁹, Lactobacillus rhamnosus HN001 10⁹, Lactobacillus paracasei LPC-37 10⁹, Bifidobacterium lactis HN019 10⁹ combined with Polydextrose.
Subjects will take two sachets per day after diluting them in 100 ml of water
PlaceboDietary supplement
The placebo sachets were prepared by substituting equivalent amounts of Maltodextrin for the probiotic powder.
Subjects will take two sachets per day after diluting them in 100 ml of water
| Study group | Role | What they receive |
|---|---|---|
| probiotic | Active comparator | Probiotic consists of Lactobacillus acidophilus NCFM, Lactobacillus rhamnosus HN001, Lactobacillus paracasei LPC-37 and Bifidobacterium lactis HN019 (Probiatop), Subjects will take two sachets per day after diluting them in 100 ml of water for 28 days. Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Placebo consists of maltodextrin. Subjects will take two sachets per day after diluting them in 100 ml of water for 28 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased number of bowel movements
Participants will record the number of defecations per day in a daily diary during the study
Measured: 28 days
Secondary outcomes (5)
Incidence of Adverse events
Participants will record the adverse events in a daily diary during study
Measured: 28 days
Changes of intestinal bacteria flora
Quantitative analysis of the participants' microbiota bacteria by sequencing the 16S rDNA gene and the readings obtained from each participant werw compared with genomic banks for identification of the microorganism.
Measured: 28 days
Improve the quality of life of participants evaluated through quality of life questionnaire
The evaluation was performed through quality of life questionnaire.
Measured: 28 days
Evaluation of symptoms of constipation
Improvement of symptoms of constipation by criteria and Bristol scale
Measured: 28 days
Improvement of symptoms of constipation
Improvement of symptoms of constipation by ROME III
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start28 Jun 2016
- Primary completion9 Aug 2016
- Study completion6 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Bacteria Flora DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Farmoquimica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ludmila Donato, Monitor, Study chair, FQM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103958
- Sponsor's protocol ID
- FE4-PROBIATOP-PA-14
- Status last verified
- Mar 2017
- First submitted
- 17 Mar 2017
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Double Blind, Randomized, Study Between Probiatop and Placebo for the Assessment of Improving the Gastrointestinal Function and Intestinal Bacterial Flora in Constipated Patients
- ClinicalTrials.gov ID
- NCT03103958
- Acronym / sponsor ID
- FE4-PROBIATOP-PA-14
- Keywords
- probiotic, metagenomic, constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Farmoquimica S.A.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2016 (actual)
- Primary completion
- 9 Aug 2016 (actual)
- Study completion
- 6 Sep 2016 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
It is a double-blind, randomized, placebo control study that evaluated the action of a probiotic in relation to a placebo in the human intestinal microbiome by the technique of metagenomics, as well as evaluated the effects of this probiotic on the gastrointestinal transit of constipated participants.
One hundred and twenty constipated patients will be randomized into two groups:Probiatop or Placebo. The first 22 patients from each group will also perform a metagenomic evaluation through the stool sample collection before and after of treatment. Besides these procedures, all patients will fill out a symptom assessment questionnaire at baseline of the study, and then after 14 and 28 days after the beginning of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| probiotic | Active comparator | Dietary Supplement: ProbioticProbiotic consists of Lactobacillus acidophilus NCFM, Lactobacillus rhamnosus HN001, Lactobacillus paracasei LPC-37 and Bifidobacterium lactis HN019 (Probiatop), Subjects will take two sachets per day after diluting them in 100 ml of water for 28 days. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo consists of maltodextrin. Subjects will take two sachets per day after diluting them in 100 ml of water for 28 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticAlso: ProbiatopProbiatop is a live microbial preparation saches containing 1g of the formulation composed by Lactobacillus acidophilus NCFM, 10⁹, Lactobacillus rhamnosus HN001 10⁹, Lactobacillus paracasei LPC-37 10⁹, Bifidobacterium lactis HN019 10⁹ combined with Polydextrose. Subjects will take two sachets per day after diluting them in 100 ml of water | Dietary supplement | probiotic |
| PlaceboThe placebo sachets were prepared by substituting equivalent amounts of Maltodextrin for the probiotic powder. Subjects will take two sachets per day after diluting them in 100 ml of water | Dietary supplement | Placebo |
Primary outcome
Increased number of bowel movements
Time frame: 28 days
Participants will record the number of defecations per day in a daily diary during the study
5 secondary outcomes
Incidence of Adverse events
Time frame: 28 days
Changes of intestinal bacteria flora
Time frame: 28 days
Improve the quality of life of participants evaluated through quality of life questionnaire
Time frame: 28 days
Evaluation of symptoms of constipation
Time frame: 28 days
Improvement of symptoms of constipation
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ludmila Donato, Monitor study chair
FQM
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Intestinal Bacteria Flora Disturbance and Constipation, run by Farmoquimica S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased number of bowel movements (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.