Functional ConstipationPROBCONNCT04437147
Effect of Probiotics on Functional Constipation in Adults
A study testing 3 Billion UFC strains of probiotics and 8 Billion UFC strains of probiotics in people with Functional Constipation, run by Luciane Cruz Lopes at 1 site in Brazil.
Trial summary
Introduction: Functional constipation is a symptom-based gastrointestinal disorder without an organic origin (eg, bowel obstruction). It has a prevalence of 14% in adults. Objective: The objective of trial is to evaluate the efficacy and safety of two different probiotic blends in adults subjects with functional… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation
- What is being tested?
- 3 Billion UFC strains of probiotics and 8 Billion UFC strains of probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- 11 Mar 2020to 28 Jan 2021
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Clinical diagnosis of functional constipation according to Rome IV. Granting of written informed consent.
Who cannot join
- Presence of gastrointestinal diseases
- Ingestion of antibiotics or dietary supplements containing probiotics or prebiotics in the last 15 days
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Probiotics on Functional Constipation in Adults: Double-blind, Randomized, Placebo-controlled Study
Introduction:
Functional constipation is a symptom-based gastrointestinal disorder without an organic origin (eg, bowel obstruction). It has a prevalence of 14% in adults.
Read more
Objective:
The objective of trial is to evaluate the efficacy and safety of two different probiotic blends in adults subjects with functional constipation.
Methods:
A double-blind, randomized, placebo-controlled study will be conducted for up to two years to evaluate the efficacy of two different probiotic mixtures: (Mixture 1) Lactobacillus acidophilus, Bifidobacterium bifidum and Lactobacillus rhamnosus (3 billion CFU); (Mixture 2) Lactobacillus acidophilus, Bifidobacterium bifidum, Lactobacillus rhamnosus, Lactobacillus paracasei, Bifidobacterium longum, Bifidobacterium lactis, Lactobacillus defensis, Bifidobacterium animallis (8 billion CFU).
Read the detailed description
The study involve 150 healthy volunteers with functional constipation.The sample size was based on literature reviews of the probiotics' effect comparing the differences between means.
After confirmation of eligibility and obtaining written informed consent, the patients will be randomized (stratification for blocks) to recivied the interventions. The patients and the phisician will be blinded to the treatment received. The eligible patients will be allocated (1:1:1) to treatment with either the probiotics supplements or placebo. Subjects will be instructed to ingest one sachet before breakfast, by mixing the powder in water and drinking it. The sachets will be stored at room temperature.
Data handling and record keeping Case report forms will be used to record data for all participants, and will be completed by the research doctor, who will also enter the data into an electronic database.
Study schedule and location After inclusion, all further treatments will be managed at the primary care center where the subject was recruited. A research doctor and a research pharmacist will be responsible for all contacts with patients.
Local of study development Recruitment of patients to this study will be made by collaboration with the Gastroenterolgy Clinic at Avenue Dr Armando Sales de Oliveira 371, Trujilo, Sorocaba, State of São Paulo, Brazil from March 2020 to April 2020. Sorocaba is a Brazilian municipality in the interior of the state of São Paulo. It is the fourth most populous in the interior of São Paulo in the Southeast of the country, and the most populous in the southern region of São Paulo, with a population of 671,186 inhabitants, estimated by IBGE for July 1, 2018.
For comparison of three groups, an independent t-test will be applied for continuous variables and Mann-Whitney for non-continuous variables. Analysis of adverse events (if any) will be performed using Chi-Square test and Fisher's exact test following assumptions of randomness, independence and size. Significance differences will be set at p<0.05.
- Conditions
- Functional Constipation
- Being tested
- Placebo, 3 Billion UFC strains of probiotics, 8 Billion UFC strains of probiotics
- Keywords
- Lactobacillus, Bifidobacterium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Also called Group Placebo
Fibers with vitamins and minerals will be administered for 30 days once a day in sachets
3 Billion UFC strains of probioticsDietary supplement
Fibers with vitamins and minerals will be administered for 30 days once a day in sachets with 3 billion CFU strains of probiotics
8 Billion UFC strains of probioticsDietary supplement
Fibers with vitamins and minerals will be administered for 30 days once a day in sachets with 8 billion CFU strains of probiotics
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | a) Control placebo (P1) Component Vitamin C (Ascorbic acid) 45 mg,Vitamin B1 (Thiamine) 1.1 mg, Vitamin B2 (Riboflavin) 1.1 mg,Vitamin D-3 40,000,000 IU / GR (Cholecalciferol) 34 mcg, Magnesium hydroxide 0.3 g, Calcium Carbonate 0.5 g, Natural Vanilla Flavor Powder 0.03 g,Fos (Fructooligosaccharides) qsp 3 g, for 30 days, once a day by sachet Receives: Dietary Supplement: Placebo |
| 3 Billion CFU strains of probiotics | Active comparator | b) 3 Billion CFU (P2) Component Lactobacillus acidophilus LA 02 ID 1688 1 billion CFU,Bifidobacterium bifidum BB 01 ID 1722 1 billion CFU, Lactobacillus rhamnosus LR 04 ID 1132 1 billion CFU,Vitamin C (Ascorbic acid) 45 mg,Vitamin B1 (Thiamine) 1.1 mg, Vitamin B2 (Riboflavin) 1.1 mg,Vitamin D-3 40,000,000 IU / GR (Cholecalciferol) 34 mcg, Magnesium hydroxide 0.3 g, Calcium Carbonate 0.5 g, Natural Vanilla Flavor Powder 0.03 g,Fos (Fructooligosaccharides) qsp 3 g, for 30 days, once a day by sachet Receives: Dietary Supplement: 3 Billion UFC strains of probiotics |
| 8 Billion CFU strains of probiotics | Active comparator | c) 8 Billion UFC (P3) Component Lactobacillus paracasei LPC 00 ID 1076 1 billion CFU;Bifidobacterium longum BL 03 ID 1152 1 billion CFU; Bifidobacterium lactis BS 01 ID 1195 1 billion CFU;Lactobacillus casei LC 03 ID 1872 1 billion CFU; Bifidobacterium animalis LMG 10508 1 billion CFU; Lactobacillus acidophilus LA 02 ID 1688 1 billion CFU,Bifidobacterium bifidum BB 01 ID 1722 1 billion CFU, Lactobacillus rhamnosus LR 04 ID 1132 1 billion CFU,Vitamin C (Ascorbic acid) 45 mg,Vitamin B1 (Thiamine) 1.1 mg, Vitamin B2 (Riboflavin) 1.1 mg,Vitamin D-3 40,000,000 IU / GR (Cholecalciferol) 34 mcg, Magnesium hydroxide 0.3 g, Calcium Carbonate 0.5 g, Natural Vanilla Flavor Powder 0.03 g,Fos (Fructooligosaccharides) qsp 3 g, for 30 days, once a day by sachet Receives: Dietary Supplement: 8 Billion UFC strains of probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changed in the number of Bowel movements. Changed for more than 3 per week was considered a clinical response.
Changed number of bowel movements evaluated weekly
Measured: 30 days
Change in the Bristol stool form scale at 4 weeks after Probiotics. Recovery to types 3-4 was considered a clinical response.
The Bristol scale ranges from 1-7, with 1-2 being constipated, 3-5 normal and 6-7 diarrhea.
Measured: 30 days
Secondary outcomes (3)
Subject withdrawal
The volunteers can withdraw from the study at any time by their own request, or can be withdrawn at any time at the discretion of the investigator for safety. Volunteers will also be withdrawn from the study in the event of treatment interruption for any reason, whether due to forgetfulness or to experiencing undue intestinal discomfort
Measured: 30 days
Adverse events
Adverse events are undesirable signs or symptoms that occur during the study and whose cause may or may not be causal related to the treatment. All adverse events considered possibly, probably or related to the test product will be noted down on the patient's form.
Measured: 30 days
Serious adverse events
Serious adverse events are defined as events that are fatal, life-threatening, disabling or result in hospitalization or prolonged stay, or result in malformation, whether related to the test product or otherwise.
According to previous studies, probiotics are safe and any serious adverse event that could possibly, probably or be related to the test products will be considered unexpected. All unexpected serious adverse events will be reported to the physician. Any serious adverse event that may be related to the test product will immediately lead to discontinuation of the test product
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start11 Mar 2020
- Primary completion30 Nov 2020
- Study completion28 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional ConstipationStudies 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
- Interventions: in particular, subjects were divided into 3 groups: i) 50 subjects in the group A will receive placebo, ii) 50 subjetcs in the group B will receive mixed L. acidophilus LA 02 ID 1688, B. bifidum BB 01 ID 1722 and L. rhamnosus LR 04 ID 1132 (1 x 10⁹ colony-forming units/d of each strain) and 50 subjects em the group C will receive L. acidophilus LA 02 ID 1688, B. bifidum BB 01 ID 1722, L. rhamnosus LR 04 ID 1132, L. paracasei LPC 00 ID 1076, B. longum BL 03 ID 1152, B. lactis BS 01 ID 1195, L. casei LC 03 ID 1872, B. animalis LMG 10508 (1 x 10⁹ colony-forming units/d of each strain) for 30 days. At the beginning of the interventional study, the healthy status of volunteers will be evaluated by a complete, laboratory and by the clinical evaluation by the doctor using as reference ROMA IV for intestinal constipation. Exclusion criteria will be items of gastrointestinal diseases, pregnant and antibiotic intake.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luciane Cruz Lopes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luciane Cruz Lopes, University of Sorocaba
- Investigators
- Fabiana R MITELMAO, master, Principal investigator, UNIVERSIDADE DE SOROCABA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437147
- Sponsor's protocol ID
- Fabiana Rosa
- Acronym
- PROBCON
- Status last verified
- Jan 2021
- First submitted
- 3 Jun 2020
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mitelmao FCR, Hackel K, Bergamaschi CC, Gerenutti M, Silva MT, Balcao VM, Vila MMDC. The effect of probiotics on functional constipation in adults: A randomized, double-blind controlled trial. Medicine (Baltimore). 2022 Oct 28;101(43):e31185. doi: 10.1097/MD.0000000000031185.
PubMed 36316826
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotics on Functional Constipation in Adults: Double-blind, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04437147
- Acronym / sponsor ID
- PROBCON / Fabiana Rosa
- Conditions
- Functional Constipation
- Keywords
- Lactobacillus, Bifidobacterium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Luciane Cruz LopesUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 28 Jan 2021 (actual)
- First posted
- 18 Jun 2020 (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.
Introduction:
Functional constipation is a symptom-based gastrointestinal disorder without an organic origin (eg, bowel obstruction). It has a prevalence of 14% in adults.
Objective:
The objective of trial is to evaluate the efficacy and safety of two different probiotic blends in adults subjects with functional constipation.
Methods:
A double-blind, randomized, placebo-controlled study will be conducted for up to two years to evaluate the efficacy of two different probiotic mixtures: (Mixture 1) Lactobacillus acidophilus, Bifidobacterium bifidum and Lactobacillus rhamnosus (3 billion CFU); (Mixture 2) Lactobacillus acidophilus, Bifidobacterium bifidum, Lactobacillus rhamnosus, Lactobacillus paracasei, Bifidobacterium longum, Bifidobacterium lactis, Lactobacillus defensis, Bifidobacterium animallis (8 billion CFU).
Detailed description
The study involve 150 healthy volunteers with functional constipation.The sample size was based on literature reviews of the probiotics' effect comparing the differences between means.
After confirmation of eligibility and obtaining written informed consent, the patients will be randomized (stratification for blocks) to recivied the interventions. The patients and the phisician will be blinded to the treatment received. The eligible patients will be allocated (1:1:1) to treatment with either the probiotics supplements or placebo. Subjects will be instructed to ingest one sachet before breakfast, by mixing the powder in water and drinking it. The sachets will be stored at room temperature.
Data handling and record keeping Case report forms will be used to record data for all participants, and will be completed by the research doctor, who will also enter the data into an electronic database.
Study schedule and location After inclusion, all further treatments will be managed at the primary care center where the subject was recruited. A research doctor and a research pharmacist will be responsible for all contacts with patients.
Local of study development Recruitment of patients to this study will be made by collaboration with the Gastroenterolgy Clinic at Avenue Dr Armando Sales de Oliveira 371, Trujilo, Sorocaba, State of São Paulo, Brazil from March 2020 to April 2020. Sorocaba is a Brazilian municipality in the interior of the state of São Paulo. It is the fourth most populous in the interior of São Paulo in the Southeast of the country, and the most populous in the southern region of São Paulo, with a population of 671,186 inhabitants, estimated by IBGE for July 1, 2018.
For comparison of three groups, an independent t-test will be applied for continuous variables and Mann-Whitney for non-continuous variables. Analysis of adverse events (if any) will be performed using Chi-Square test and Fisher's exact test following assumptions of randomness, independence and size. Significance differences will be set at p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Interventions: in particular, subjects were divided into 3 groups: i) 50 subjects in the group A will receive placebo, ii) 50 subjetcs in the group B will receive mixed L. acidophilus LA 02 ID 1688, B. bifidum BB 01 ID 1722 and L. rhamnosus LR 04 ID 1132 (1 x 10⁹ colony-forming units/d of each strain) and 50 subjects em the group C will receive L. acidophilus LA 02 ID 1688, B. bifidum BB 01 ID 1722, L. rhamnosus LR 04 ID 1132, L. paracasei LPC 00 ID 1076, B. longum BL 03 ID 1152, B. lactis BS 01 ID 1195, L. casei LC 03 ID 1872, B. animalis LMG 10508 (1 x 10⁹ colony-forming units/d of each strain) for 30 days. At the beginning of the interventional study, the healthy status of volunteers will be evaluated by a complete, laboratory and by the clinical evaluation by the doctor using as reference ROMA IV for intestinal constipation. Exclusion criteria will be items of gastrointestinal diseases, pregnant and antibiotic intake.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placeboa) Control placebo (P1) Component Vitamin C (Ascorbic acid) 45 mg,Vitamin B1 (Thiamine) 1.1 mg, Vitamin B2 (Riboflavin) 1.1 mg,Vitamin D-3 40,000,000 IU / GR (Cholecalciferol) 34 mcg, Magnesium hydroxide 0.3 g, Calcium Carbonate 0.5 g, Natural Vanilla Flavor Powder 0.03 g,Fos (Fructooligosaccharides) qsp 3 g, for 30 days, once a day by sachet |
| 3 Billion CFU strains of probiotics | Active comparator | Dietary Supplement: 3 Billion UFC strains of probioticsb) 3 Billion CFU (P2) Component Lactobacillus acidophilus LA 02 ID 1688 1 billion CFU,Bifidobacterium bifidum BB 01 ID 1722 1 billion CFU, Lactobacillus rhamnosus LR 04 ID 1132 1 billion CFU,Vitamin C (Ascorbic acid) 45 mg,Vitamin B1 (Thiamine) 1.1 mg, Vitamin B2 (Riboflavin) 1.1 mg,Vitamin D-3 40,000,000 IU / GR (Cholecalciferol) 34 mcg, Magnesium hydroxide 0.3 g, Calcium Carbonate 0.5 g, Natural Vanilla Flavor Powder 0.03 g,Fos (Fructooligosaccharides) qsp 3 g, for 30 days, once a day by sachet |
| 8 Billion CFU strains of probiotics | Active comparator | Dietary Supplement: 8 Billion UFC strains of probioticsc) 8 Billion UFC (P3) Component Lactobacillus paracasei LPC 00 ID 1076 1 billion CFU;Bifidobacterium longum BL 03 ID 1152 1 billion CFU; Bifidobacterium lactis BS 01 ID 1195 1 billion CFU;Lactobacillus casei LC 03 ID 1872 1 billion CFU; Bifidobacterium animalis LMG 10508 1 billion CFU; Lactobacillus acidophilus LA 02 ID 1688 1 billion CFU,Bifidobacterium bifidum BB 01 ID 1722 1 billion CFU, Lactobacillus rhamnosus LR 04 ID 1132 1 billion CFU,Vitamin C (Ascorbic acid) 45 mg,Vitamin B1 (Thiamine) 1.1 mg, Vitamin B2 (Riboflavin) 1.1 mg,Vitamin D-3 40,000,000 IU / GR (Cholecalciferol) 34 mcg, Magnesium hydroxide 0.3 g, Calcium Carbonate 0.5 g, Natural Vanilla Flavor Powder 0.03 g,Fos (Fructooligosaccharides) qsp 3 g, for 30 days, once a day by sachet |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Clinical diagnosis of functional constipation according to Rome IV. Granting of written informed consent.
Key exclusion criteria (3 listed)
- Presence of gastrointestinal diseases
- Ingestion of antibiotics or dietary supplements containing probiotics or prebiotics in the last 15 days
- Pregnancy.
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 |
|---|---|---|
| PlaceboAlso: Group PlaceboFibers with vitamins and minerals will be administered for 30 days once a day in sachets | Dietary supplement | Placebo |
| 3 Billion UFC strains of probioticsFibers with vitamins and minerals will be administered for 30 days once a day in sachets with 3 billion CFU strains of probiotics | Dietary supplement | 3 Billion CFU strains of probiotics |
| 8 Billion UFC strains of probioticsFibers with vitamins and minerals will be administered for 30 days once a day in sachets with 8 billion CFU strains of probiotics | Dietary supplement | 8 Billion CFU strains of probiotics |
Primary outcome
Changed in the number of Bowel movements. Changed for more than 3 per week was considered a clinical response.
Time frame: 30 days
Changed number of bowel movements evaluated weekly
Change in the Bristol stool form scale at 4 weeks after Probiotics. Recovery to types 3-4 was considered a clinical response.
Time frame: 30 days
The Bristol scale ranges from 1-7, with 1-2 being constipated, 3-5 normal and 6-7 diarrhea.
3 secondary outcomes
Subject withdrawal
Time frame: 30 days
Adverse events
Time frame: 30 days
Serious adverse events
Time frame: 30 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 29 Jan 2021.
- Derived from this study: PubMed 36316826Mitelmao FCR, Hackel K, Bergamaschi CC, Gerenutti M, Silva MT, Balcao VM, Vila MMDC. The effect of probiotics on functional constipation in adults: A randomized, double-blind controlled trial. Medicine (Baltimore). 2022 Oct 28;101(43):e31185. doi: 10.1097/MD.0000000000031185.
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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.
Fabiana R MITELMAO, master principal investigator
UNIVERSIDADE DE SOROCABA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 Billion UFC strains of probiotics and 8 Billion UFC strains of probiotics in people with Functional Constipation, run by Luciane Cruz Lopes at 1 site in Brazil.
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 1 inclusion and 3 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 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Changed in the number of Bowel movements. Changed for more than 3 per week was considered a clinical response. (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04437147, which also lists 1 linked publication.
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 29 Jan 2021.