HealthyBIOPOLISNCT05367427
Heat-treated Postbiotic Consumption in Healthy People With Mild to Moderate Gastrointestinal Symptoms
A study testing Heat treated postbiotic Bifidobacterium Longum consumption in people with Healthy and Gastrointestinal Dysfunction, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
The use of probiotics is a widespread clinical practice to improve the composition of the microbiota in healthy and pathological patients. However, in recent years, postbiotics have begun to be used that can exert a certain anti-inflammatory effect at the intestinal level. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Gastrointestinal Dysfunction
- What is being tested?
- Heat treated postbiotic Bifidobacterium Longum consumption
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2022to 31 Oct 2022
- 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
- Subjects who obtain a score between 13 and 39 points with diarrhea predominance in the Gastrointestinal Symptoms Rating Scale (GSRS-IBS) corresponding to the last week.
- Men and women between 18 and 65 years old.
- Absence of a family or social environment that prevents compliance with treatment.
- Adequate cultural level and understanding of the clinical study.
- Agree to voluntarily participate in the study and give their informed consent in writing.
Who cannot join
- Subjects with BMI <18.5 or >35 kg/m2.
- Subjects who have participated in programs and/or clinical trials and who have lost or gained more than 4 kg in the last 3 months.
- Subjects diagnosed with Diabetes Mellitus 1 or 2.
- Subjects diagnosed with metabolic syndrome, hypothyroidism and/or hyperthyroidism.
- Subjects with allergies to the excipients of the product/placebo.
- Subjects with an established diagnosis of eating behavior disorder.
Show all 23Show fewer
- Women who do not agree to continue with their contraceptive method during the study period.
- Subjects who perform excessive physical exercise (>2 h more than 3 times per week).
- Subjects who wish to start an exercise plan and/or dietary program during the study period.
- Subjects with serious diseases (liver disease, kidney disease, heart disease, lung disease, cancer, etc.).
- Subjects with chronic intestinal pathologies (gastritis, ulcerative colitis, irritable bowel syndrome, inflammatory bowel disease, Crohn's disease, intestinal perforation, history of gastroparesis, etc.).
- Subjects with autoimmune diseases and/or subjects undergoing treatment with corticosteroids, immunosuppressants and/or biologicals in the last 12 months.
- Subjects with major surgeries in the last 3 months or gastrointestinal surgery in the last 6 months.
- Subjects with weight loss surgery (gastric bypass, lap band)
- Subjects under treatment with oral antibiotics during the 30 days prior to the start of the study.
- Subjects with recent episodes of acute gastrointestinal illness such as nausea, vomiting or acute gastroenteritis 2 weeks before the start of the study.
- Subjects who wish to quit smoking during the duration of the study.
- Subjects who consume antioxidant supplements, omega 3 supplements, vitamins, minerals, prebiotic, synbiotic, parabiotic or probiotic products in the 4 weeks prior to the start of the study and who do not agree to suppress their consumption during the study period.
- Subjects with alcohol consumption greater than 30 g/day (equivalent to 300 ml of wine, about 3 beers or a glass (75 ml) of whisky, cognac, anise, etc.)).
- Subjects with regular use of antidiarrheal medications (>2 per week) during the last 3 months prior to the start of the study.
- Subjects on anticoagulant therapy.
- Subjects with dementia, mental illness, or decreased cognitive function.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Evaluate the Effect of Regular Consumption of a Heath-treated Postbiotic on the Improvement of Symptoms in People With Mild to Moderate Gastrointestinal Disorders Not Associated With Disease
The use of probiotics is a widespread clinical practice to improve the composition of the microbiota in healthy and pathological patients. However, in recent years, postbiotics have begun to be used that can exert a certain anti-inflammatory effect at the intestinal level. Among them, Bifidobacterium longum (CECT 7347) has been used in various clinical trials with promising results. It has immunoregulatory properties and an excellent ability to attenuate the activity of epithelial cells at the intestinal level. However, it is necessary to carry out clinical trials to verify its effects, preferably in healthy patients who show certain gastrointestinal discomfort. For this reason, a parallel, randomized, double-blind, controlled pilot clinical trial with 2 study arms has been proposed to assess the effect of habitual consumption of a heat treated postbiotic B. longum CECT 7347 on mild-moderate functional digestive disorders in a group of healthy people.
Read the detailed description
Recently, there has been a great advance in functional digestive disorders research by new methodological strategies development for their treatment. One of the most interesting line broads the use of microorganisms with the aim of reducing the gastrointestinal. The most studied in this context belong to the genus Bifidobacterium. These microorganisms have shown a remarkable capacity to modulate the inflammatory response, whose efficacy was previously evaluated in celiac patients. Subsequently, different in vitro studies and animal models has been carried out on Bifidobacterium strains, specifically B. longum CECT 7347. Its effect on inflammation caused by gliadins, has reported promising results. This strain is characterized by its anti-inflammatory activity and its ability to recover the intestinal barrier.
Clinical trials in humans took place once the genome of the B. longum CECT 7347 strain and its safety at the level of oral consumption were studied. Continuing with the work carried out in animal models, the efficacy of oral consumption in celiac patients was evaluated, although studies were also carried out on other individuals with liver or dermatological pathologies.
Gastrointestinal symptoms in adults are usually predominant and have important consequences for health and quality of life. In addition, recent studies suggest that the composition of the intestinal microbiota in those people who have gastrointestinal symptoms may come from intestinal dysbiosis, highlighting the role in the noticeable symptoms. Digestive disorders are characterized by compositional imbalances in the gut microbiota, particularly by a reduced number on both total bifidobacteria and Bifidobacterium longum ES1 (CECT 7347). Recent in vitro studies have shown that the presence of B. longum CECT 7347 reduces the toxic and inflammatory effects on intestinal cells.
The former evidences it has been hypothesised that the administration of a heat treated postbiotic B. longum CECT 7347 could modify the composition of the intestinal microbiota due to its immunoregulatory properties and the ability to attenuate the activity of epithelial cells. The proper administrations should attenuate the inflammatory effects, producing a decrease in the prevalence of gastrointestinal symptoms in undiagnosed groups, but which may suffer from a certain intestinal dysbiosis. Based on the above background, a parallel, randomized, double-blind, controlled pilot clinical trial with two study arms has been proposed to assess the effect of habitual consumption of heat treated postbiotic B. longum CECT 7347 on mild to moderate functional digestive disorders in a group of healthy people.
- Conditions
- Healthy, Gastrointestinal Dysfunction
- Being tested
- Heat treated postbiotic Bifidobacterium Longum consumption, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat treated postbiotic Bifidobacterium Longum consumptionDietary supplement
Also called Experimental
Regular consumption in breakfast of heat treated postbiotic B. longum
PlaceboDietary supplement
Also called Control
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Heat treated postbiotic Bifidobacterium Longum | Experimental | Consumption of 2 capsules/day of Bifidobacterium Longum CECT 7347 (Total daily equivalent of 2.5 x 10^9 CFU) Receives: Dietary Supplement: Heat treated postbiotic Bifidobacterium Longum consumption |
| Placebo | Placebo comparator | Consumption of 2 placebo capsules/day filled with maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of gastrointestinal symptoms
Changes in the score obtained through the Gastrointestinal Symptom Rating of Irritable Bowel Syndrome (GSRS-IBS) scale (Score range: 0-78 points). A greater score means a higher occurrence of gastrointestinal symptoms.
Measured: Day 0 - Day 60
Secondary outcomes (35)
Frequency of gastrointestinal symptoms
Changes in the score obtained through the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) scale (Score range: 0-500 points). A greater score punctuation means a higher frequency of gastrointestinal symptoms.
Measured: Day 0 - Day 60
Gastrointestinal quality of life
Changes in the score obtained in the gastrointestinal quality of life questionnaire (GIQLI) (Score range: 0-144 points). A higher score means a better perception of gastrointestinal quality of life.
Measured: Day 0 - Day 60
Defecation pattern
Modifications in the defecation pattern of the Bristol Scale, decreasing stools with a 5-7 assessment and observing a greater presence of stools with a 3-4 value. Ideal scores range between 3-4; constipation occurs in 1-2 scores and the presence of diarrhoea in highlighted with stools of 5, 6 and 7 description.
Measured: Day 0-Day 60
Visceral sensitivity
Changes in Visceral Sensitivity Index (VSI) score (Range: 15-90). A lower score means an undesirable visceral sensitivity.
Measured: Day 0- Day 60
Zonulin concentration
Changes in fecal zonulin concentration, as a biomarker related to increased intestinal permeability
Measured: Day 0 - Day 60
Faecal microbiome analysis
Changes in feacal microbiome after heat treated postbiotic
Measured: Day 0 vs Day 60
Glucose
Maintenance of biochemical parameters within normal concentrations (74-106 mg/dL)
Measured: Day 0 - Day 60
Total serum protein
Maintenance of biochemical parameters within normal concentrations of total serum proteins (range from 6.4 to 8.3 g/dL)
Measured: Day 0 - Day 60
Serum albumin
Maintenance of biochemical parameters within normal concentrations of serum albumin (range from 3.4 to 5.4 g/dL)
Measured: Day 0 - Day 60
HDL-cholesterol
Maintenance of biochemical parameters within normal serum concentrations of HDL-cholesterol (♂: >40, ♀: >50 mg/dL)
Measured: Day 0 - Day 60
Serum prealbumin
Maintenance of biochemical parameters within normal concentrations of serum prealbumin (range from 17 to 42 mg/dL)
Measured: Day 0 - Day 60
Cholesterol
Maintenance of biochemical parameters within normal serum concentrations of total cholesterol (<200 mg/dL)
Measured: Day 0 - Day 60
LDL-cholesterol
Maintenance of biochemical parameters within normal serum concentrations of LDL-cholesterol (<130 mg/dL)
Measured: Day 0 - Day 60
Triglycerides
Maintenance of biochemical parameters within normal serum concentrations of triglycerides (TG) (<150 mg/dL)
Measured: Day 0 - Day 60
Vitamin A
Maintenance of biochemical parameters within normal serum concentrations of vitamin A (0.3-0.7 ug/mL)
Measured: Day 0 - Day 60
Vitamin E
Maintenance of biochemical parameters within normal serum concentrations of vitamin E (5-20 ug/mL)
Measured: Day 0 - Day 60
Vitamin D
Maintenance of biochemical parameters within normal serum concentrations of vitamin D (30-100 ng/mL)
Measured: Day 0 - Day 60
Calcium
Maintenance of biochemical parameters within normal serum concentrations of Calcium (8.6-10,2 mg/dL)
Measured: Day 0 - Day 60
Phosphorus
Maintenance of biochemical parameters within normal serum concentrations of Phosphorus (2.5-4.5 mg/dL)
Measured: Day 0 - Day 60
Sodium
Maintenance of biochemical parameters within normal serum concentrations of Sodium (136-145 mmol/L)
Measured: Day 0 - Day 60
Potassium
Maintenance of biochemical parameters within normal serum concentrations of Potassium (3.5-5.1 mmol/L)
Measured: Day 0 - Day 60
Magnesium
Maintenance of biochemical parameters within normal serum concentrations of Magnesium (1.60-2.60 mg/dL)
Measured: Day 0 - Day 60
Chlorine
Maintenance of biochemical parameters within normal serum concentrations of Chlorine (99-109 mmol/L)
Measured: Day 0 - Day 60
Folic Acid
Maintenance of biochemical parameters within normal serum concentrations of Folic Acid (>2,6 ng/dL)
Measured: Day 0 - Day 60
Vitamin B12
Maintenance of biochemical parameters within normal serum concentrations of Vitamin B12 (211-911 pg/mL).
Measured: Day 0 - Day 60
Interleukins
Changes in inflammatory m. These biomarkers are measured in pg/mL
Measured: Day 0 - Day 60
C-reactive protein (CRP)
Modifications in the C-reactive protein (CRP). This biomarker is measured in mg/L
Measured: Day 0 - Day 60
Body weight
Changes produced in body weight measured in kilograms
Measured: Day 0 - Day 60
Waist circumference
Data referring to the waist circumference of the Spanish population allow to estimate cardiovascular risk parameters from 95 cm in men and 82 cm in women, and very high risk from 102 cm in men and 90 cm in women. The measurement is taken at the narrowest point between the last rib and the iliac crest, with the tape against the skin but not compressed. The person should be kept in an upright position, distributing the weight equally on both legs and their arms relaxed at the sides of the body.
Measured: Day 0 - Day 60
Body mass index (BMI)
Relationship between body weight (kg) and height (m) squared of the individual: Weight/(Height)2
Measured: Day 0 - Day 60
Fat mass percentage
Changes or maintenance of the fat mass % measured by electrical bioimpedance
Measured: Day 0 - Day 60
Muscle Mass percentage
Changes or maintenance of the muscle mass % measured by electrical bioimpedance
Measured: Day 0 - Day 60
Blood pressure
Maintenance in systolic pressure and diastolic pressure measured by blood pressure monitor
Measured: Day 0 - Day 60
Heart rate
Heart rate maintenance measured in beats per minute (bpm) using blood pressure monitor
Measured: Day 0 - Day 60
Tolerance
Changes measured by applying a tolerance questionnaire that evaluates qualitative information on possible symptoms associated with the consumption of the product such as: nausea, heartburn, diarrhea, abdominal distension or halitosis.
Measured: Day 0 - Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 Feb 2022
- Primary completion31 Jul 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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, randomized, double-blind, controlled pilot clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Biopolis S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367427
- Sponsor's protocol ID
- HULP 6010
- Acronym
- BIOPOLIS
- Status last verified
- Jun 2024
- First submitted
- 10 Feb 2022
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Effect of Regular Consumption of a Heath-treated Postbiotic on the Improvement of Symptoms in People With Mild to Moderate Gastrointestinal Disorders Not Associated With Disease
- ClinicalTrials.gov ID
- NCT05367427
- Acronym / sponsor ID
- BIOPOLIS / HULP 6010
- Conditions
- Healthy, Gastrointestinal Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Biopolis S.L.
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 10 May 2022 (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 use of probiotics is a widespread clinical practice to improve the composition of the microbiota in healthy and pathological patients. However, in recent years, postbiotics have begun to be used that can exert a certain anti-inflammatory effect at the intestinal level. Among them, Bifidobacterium longum (CECT 7347) has been used in various clinical trials with promising results. It has immunoregulatory properties and an excellent ability to attenuate the activity of epithelial cells at the intestinal level. However, it is necessary to carry out clinical trials to verify its effects, preferably in healthy patients who show certain gastrointestinal discomfort. For this reason, a parallel, randomized, double-blind, controlled pilot clinical trial with 2 study arms has been proposed to assess the effect of habitual consumption of a heat treated postbiotic B. longum CECT 7347 on mild-moderate functional digestive disorders in a group of healthy people.
Detailed description
Recently, there has been a great advance in functional digestive disorders research by new methodological strategies development for their treatment. One of the most interesting line broads the use of microorganisms with the aim of reducing the gastrointestinal. The most studied in this context belong to the genus Bifidobacterium. These microorganisms have shown a remarkable capacity to modulate the inflammatory response, whose efficacy was previously evaluated in celiac patients. Subsequently, different in vitro studies and animal models has been carried out on Bifidobacterium strains, specifically B. longum CECT 7347. Its effect on inflammation caused by gliadins, has reported promising results. This strain is characterized by its anti-inflammatory activity and its ability to recover the intestinal barrier.
Clinical trials in humans took place once the genome of the B. longum CECT 7347 strain and its safety at the level of oral consumption were studied. Continuing with the work carried out in animal models, the efficacy of oral consumption in celiac patients was evaluated, although studies were also carried out on other individuals with liver or dermatological pathologies.
Gastrointestinal symptoms in adults are usually predominant and have important consequences for health and quality of life. In addition, recent studies suggest that the composition of the intestinal microbiota in those people who have gastrointestinal symptoms may come from intestinal dysbiosis, highlighting the role in the noticeable symptoms. Digestive disorders are characterized by compositional imbalances in the gut microbiota, particularly by a reduced number on both total bifidobacteria and Bifidobacterium longum ES1 (CECT 7347). Recent in vitro studies have shown that the presence of B. longum CECT 7347 reduces the toxic and inflammatory effects on intestinal cells.
The former evidences it has been hypothesised that the administration of a heat treated postbiotic B. longum CECT 7347 could modify the composition of the intestinal microbiota due to its immunoregulatory properties and the ability to attenuate the activity of epithelial cells. The proper administrations should attenuate the inflammatory effects, producing a decrease in the prevalence of gastrointestinal symptoms in undiagnosed groups, but which may suffer from a certain intestinal dysbiosis. Based on the above background, a parallel, randomized, double-blind, controlled pilot clinical trial with two study arms has been proposed to assess the effect of habitual consumption of heat treated postbiotic B. longum CECT 7347 on mild to moderate functional digestive disorders in a group of healthy people.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Parallel, randomized, double-blind, controlled pilot clinical trial
| Arm | Type | Receives |
|---|---|---|
| Heat treated postbiotic Bifidobacterium Longum | Experimental | Dietary Supplement: Heat treated postbiotic Bifidobacterium Longum consumptionConsumption of 2 capsules/day of Bifidobacterium Longum CECT 7347 (Total daily equivalent of 2.5 x 10^9 CFU) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboConsumption of 2 placebo capsules/day filled with maltodextrin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who obtain a score between 13 and 39 points with diarrhea predominance in the Gastrointestinal Symptoms Rating Scale (GSRS-IBS) corresponding to the last week.
- Men and women between 18 and 65 years old.
- Absence of a family or social environment that prevents compliance with treatment.
- Adequate cultural level and understanding of the clinical study.
- Agree to voluntarily participate in the study and give their informed consent in writing.
Key exclusion criteria (23 listed)
- Subjects with BMI <18.5 or >35 kg/m2.
- Subjects who have participated in programs and/or clinical trials and who have lost or gained more than 4 kg in the last 3 months.
- Subjects diagnosed with Diabetes Mellitus 1 or 2.
- Subjects diagnosed with metabolic syndrome, hypothyroidism and/or hyperthyroidism.
- Subjects with allergies to the excipients of the product/placebo.
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 |
|---|---|---|
| Heat treated postbiotic Bifidobacterium Longum consumptionAlso: ExperimentalRegular consumption in breakfast of heat treated postbiotic B. longum | Dietary supplement | Heat treated postbiotic Bifidobacterium Longum |
| PlaceboAlso: ControlMaltodextrin | Dietary supplement | Placebo |
Primary outcome
Occurrence of gastrointestinal symptoms
Time frame: Day 0 - Day 60
Changes in the score obtained through the Gastrointestinal Symptom Rating of Irritable Bowel Syndrome (GSRS-IBS) scale (Score range: 0-78 points). A greater score means a higher occurrence of gastrointestinal symptoms.
35 secondary outcomes
Frequency of gastrointestinal symptoms
Time frame: Day 0 - Day 60
Gastrointestinal quality of life
Time frame: Day 0 - Day 60
Defecation pattern
Time frame: Day 0-Day 60
Visceral sensitivity
Time frame: Day 0- Day 60
Zonulin concentration
Time frame: Day 0 - Day 60
Faecal microbiome analysis
Time frame: Day 0 vs Day 60
Glucose
Time frame: Day 0 - Day 60
Total serum protein
Time frame: Day 0 - Day 60
Serum albumin
Time frame: Day 0 - Day 60
HDL-cholesterol
Time frame: Day 0 - Day 60
Serum prealbumin
Time frame: Day 0 - Day 60
Cholesterol
Time frame: Day 0 - Day 60
LDL-cholesterol
Time frame: Day 0 - Day 60
Triglycerides
Time frame: Day 0 - Day 60
Vitamin A
Time frame: Day 0 - Day 60
Vitamin E
Time frame: Day 0 - Day 60
Vitamin D
Time frame: Day 0 - Day 60
Calcium
Time frame: Day 0 - Day 60
Phosphorus
Time frame: Day 0 - Day 60
Sodium
Time frame: Day 0 - Day 60
Potassium
Time frame: Day 0 - Day 60
Magnesium
Time frame: Day 0 - Day 60
Chlorine
Time frame: Day 0 - Day 60
Folic Acid
Time frame: Day 0 - Day 60
Vitamin B12
Time frame: Day 0 - Day 60
Interleukins
Time frame: Day 0 - Day 60
C-reactive protein (CRP)
Time frame: Day 0 - Day 60
Body weight
Time frame: Day 0 - Day 60
Waist circumference
Time frame: Day 0 - Day 60
Body mass index (BMI)
Time frame: Day 0 - Day 60
Fat mass percentage
Time frame: Day 0 - Day 60
Muscle Mass percentage
Time frame: Day 0 - Day 60
Blood pressure
Time frame: Day 0 - Day 60
Heart rate
Time frame: Day 0 - Day 60
Tolerance
Time frame: Day 0 - Day 60
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 15 Aug 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 Heat treated postbiotic Bifidobacterium Longum consumption in people with Healthy and Gastrointestinal Dysfunction, run by Instituto de Investigación Hospital Universitario La Paz 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 5 inclusion and 23 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 15 Aug 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?
Occurrence of gastrointestinal symptoms (time frame: Day 0 - Day 60). 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 15 Aug 2024.