Functional ConstipationNCT06381193
Study for the Management of Chronic and Functional Constipation Through the Intake of Probiotics and Prebiotics
A study testing Probiotic, Prebiotic and Probiotic + Prebiotic in people with Functional Constipation, run by Centros de Investigación de Nutrición y Salud at 1 site in Spain.
Trial summary
The goal of this clinical trial is to learn if supplementation with prebiotics and/or probiotics can lead to an improvement in symptoms of patients with functional constipation. The main objectives are: To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation
- What is being tested?
- Probiotic, Prebiotic and Probiotic + Prebiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 3 Mar 2023to 10 Jul 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women between 18-65.
- BMI 18.5-39.9 kg/m2
- According to the ROME IV criteria, patients with functional constipation who meet the following conditions for at least the last three months and with symptoms for at least 6 months before diagnosis:
- The presence of two or more of the following criteria:
- Excessive straining at least in 25% of bowel movements.
- Hard stools (types 1-2 on the Bristol scale) at least in 25% of stools.
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- Sensation of incomplete evacuation at least in 25% of the stools.
- Sensation of anorectal obstruction or blockage at least in 25% of bowel movements.
- Manual maneuvers to facilitate defecation at least in 25% of stools.
- Less than three complete spontaneous bowel movements per week.
- Diarrhea rarely occurs without the use of laxatives.
- Insufficient criteria for the diagnosis of irritable bowel syndrome.
- Or, according to the ROME IV criteria, patients who suffer from constipation type irritable bowel syndrome defined as a syndrome in which there is abdominal pain with at least two of the following three characteristics:
- Related to defecation.
- Associated with change in stool frequency.
- Associated with a change in stool shape or appearance.
- Patients who have signed the informed consent.
- Patients with the ability to understand and carry out the study procedures.
- Women participating in the study must meet one of these two conditions:
- Women without the possibility of becoming pregnant, defined as any woman who has undergone surgical sterilization or is in a postmenopausal state.
- Women with the possibility of becoming pregnant who regularly use a highly effective contraceptive method (i.e., hormonal contraception, intrauterine device, condoms, sterilization of the male partner (vasectomy), or complete sexual abstinence) while participating in the study.
Who cannot join
- Minors under 18 or over 65 years of age.
- Patients diagnosed with other chronic diseases ( Parkinson's or other dementias, cerebral palsy, heart attack, tetraplegia, hemiplegia, intellectual disability, multiple sclerosis, amyotrophic lateral sclerosis (ALS), cystic fibrosis, congenital metabolic diseases, eating disorders).
- With previous surgeries in the gastrointestinal tract.
- Patients with scheduled surgical interventions during the study.
- Patient treated with anticoagulants.
- Patients who have used laxative treatment during the 15 days before the start of the study.
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- Patients who have been treated with antibiotics in the last month.
- Usual treatment with opioid analgesics.
- Consumption of supplements with probiotics or prebiotics during the last two weeks before inclusion in the study.
- Patients diagnosed or with sufficient criteria for the diagnosis of ulcerative colitis, Crohn's disease, presence of intestinal obstruction or malignant disease in the gastrointestinal tract.
- Participation in another clinical trial with an investigational medication 30 days before the start of the study.
- Pregnant or breastfeeding women.
- Patients with hypersensitivity, allergy or intolerance to any of the components of the food supplements in the study
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centros de Investigación en Nutrición y Salud SL. (Clínica CINUSA)
Madrid, 28036
About this study
The goal of this clinical trial is to learn if supplementation with prebiotics and/or probiotics can lead to an improvement in symptoms of patients with functional constipation. The main objectives are:
- To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation, after 8 weeks.
- To evaluate the stool consistency after 8 weeks (Bristol scale).
- To evaluate the quality of life scale score for patients with Constipation (CVE20 and GSRS scales), after 8 weeks.
Read more
Participants are randomized into the following groups:
- Group A: 20 assigned to probiotic + placebo
- Group B: 20 assigned to prebiotic + placebo
- Group C: 20 assigned to probiotic + prebiotic
- Group D: 20 assigned to the placebo + placebo
Participants took 4 units of product per day (2 of each assigned product) for 2 months.
- Conditions
- Functional Constipation
- Being tested
- Probiotic, Prebiotic, Probiotic + Prebiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
oral, daily
PrebioticDietary supplement
oral, daily
Probiotic + PrebioticDietary supplement
oral, daily
PlaceboDietary supplement
oral, daily
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Dietary Supplement: Probiotic |
| Group B | Experimental | Not described Receives: Dietary Supplement: Prebiotic |
| Group C | Experimental | Not described Receives: Dietary Supplement: Probiotic + Prebiotic |
| Group D | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation.
Measured: 8 weeks
Secondary outcomes (3)
To evaluate the stool consistency (Bristol scale).
Type 1-7 (types 3 and 4 indicate a regular transit)
Measured: 8 weeks
To evaluate the quality of life scale score for patients with constipation (Quality of life questionnaire for patients with constipation, CVE-20)
Measured: 8 weeks
To evaluate the quality of life scale score for patients with constipation (Gastrointestinal Symptom Assessment Scale, GSRS scale).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start3 Mar 2023
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centros de Investigación de Nutrición y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Nutribiotica
- Responsible party
- Principal investigator, Ismael San Mauro Martin, Centros de Investigación de Nutrición y Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381193
- Sponsor's protocol ID
- ESTR-01-2022
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the Management of Chronic and Functional Constipation Through the Intake of Probiotics and Prebiotics
- ClinicalTrials.gov ID
- NCT06381193
- Acronym / sponsor ID
- ESTR-01-2022
- Conditions
- Functional Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centros de Investigación de Nutrición y SaludUniversity, hospital or other
- Collaborators
- Nutribiotica
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 24 Apr 2024 (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 goal of this clinical trial is to learn if supplementation with prebiotics and/or probiotics can lead to an improvement in symptoms of patients with functional constipation. The main objectives are:
- To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation, after 8 weeks.
- To evaluate the stool consistency after 8 weeks (Bristol scale).
- To evaluate the quality of life scale score for patients with Constipation (CVE20 and GSRS scales), after 8 weeks.
Participants are randomized into the following groups:
- Group A: 20 assigned to probiotic + placebo
- Group B: 20 assigned to prebiotic + placebo
- Group C: 20 assigned to probiotic + prebiotic
- Group D: 20 assigned to the placebo + placebo
Participants took 4 units of product per day (2 of each assigned product) for 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Dietary Supplement: Probiotic |
| Group B | Experimental | Dietary Supplement: Prebiotic |
| Group C | Experimental | Dietary Supplement: Probiotic + Prebiotic |
| Group D | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Men or women between 18-65.
- BMI 18.5-39.9 kg/m2
- According to the ROME IV criteria, patients with functional constipation who meet the following conditions for at least the last three months and with symptoms for at least 6 months before diagnosis:
- Or, according to the ROME IV criteria, patients who suffer from constipation type irritable bowel syndrome defined as a syndrome in which there is abdominal pain with at least two of the following three characteristics:
- Patients who have signed the informed consent.
Key exclusion criteria (13 listed)
- Minors under 18 or over 65 years of age.
- Patients diagnosed with other chronic diseases ( Parkinson's or other dementias, cerebral palsy, heart attack, tetraplegia, hemiplegia, intellectual disability, multiple sclerosis, amyotrophic lateral sclerosis (ALS), cystic fibrosis, congenital metabolic diseases, eating disorders).
- With previous surgeries in the gastrointestinal tract.
- Patients with scheduled surgical interventions during the study.
- Patient treated with anticoagulants.
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 |
|---|---|---|
| Probioticoral, daily | Dietary supplement | Group A |
| Prebioticoral, daily | Dietary supplement | Group B |
| Probiotic + Prebioticoral, daily | Dietary supplement | Group C |
| Placebooral, daily | Dietary supplement | Group D |
Primary outcome
1. To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation.
Time frame: 8 weeks
3 secondary outcomes
To evaluate the stool consistency (Bristol scale).
Time frame: 8 weeks
To evaluate the quality of life scale score for patients with constipation (Quality of life questionnaire for patients with constipation, CVE-20)
Time frame: 8 weeks
To evaluate the quality of life scale score for patients with constipation (Gastrointestinal Symptom Assessment Scale, GSRS scale).
Time frame: 8 weeks
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 24 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic, Prebiotic and Probiotic + Prebiotic in people with Functional Constipation, run by Centros de Investigación de Nutrición y Salud at 1 site in Spain.
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 21 inclusion and 13 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 24 Apr 2024. 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 Spain. 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?
1. To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation. (time frame: 8 weeks). 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 24 Apr 2024.