Heat-treated Postbiotic Consumption in Healthy People With Mild to Moderate Gastrointestinal Symptoms (BIOPOLIS)

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Gastrointestinal Dysfunction
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Heat treated postbiotic Bifidobacterium Longum consumption

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Institute for Health Research IdiPAZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heat treated postbiotic Bifidobacterium Longum; Consumption of 2 capsules/day of Bifidobacterium Longum CECT 7347 (Total daily equivalent of 2.5 x 10^9 CFU)	Dietary supplement: Heat treated postbiotic Bifidobacterium Longum consumption; Regular consumption in breakfast of heat treated postbiotic B. longum; Other Names: Experimental
Placebo Comparator: Placebo; Consumption of 2 placebo capsules/day filled with maltodextrin	Dietary supplement: Placebo; Maltodextrin; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0 - Day 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Day 0-Day 60
Glucose	Maintenance of biochemical parameters within normal concentrations (74-106 mg/dL)	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)	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)	Day 0 - Day 60
Serum prealbumin	Maintenance of biochemical parameters within normal concentrations of serum prealbumin (range from 17 to 42 mg/dL)	Day 0 - Day 60
Cholesterol	Maintenance of biochemical parameters within normal serum concentrations of total cholesterol (<200 mg/dL)	Day 0 - Day 60
HDL-cholesterol	Maintenance of biochemical parameters within normal serum concentrations of HDL-cholesterol (♂: >40, ♀: >50 mg/dL)	Day 0 - Day 60
LDL-cholesterol	Maintenance of biochemical parameters within normal serum concentrations of LDL-cholesterol (<130 mg/dL)	Day 0 - Day 60
Triglycerides	Maintenance of biochemical parameters within normal serum concentrations of triglycerides (TG) (<150 mg/dL)	Day 0 - Day 60
Vitamin A	Maintenance of biochemical parameters within normal serum concentrations of vitamin A (0.3-0.7 ug/mL)	Day 0 - Day 60
Vitamin E	Maintenance of biochemical parameters within normal serum concentrations of vitamin E (5-20 ug/mL)	Day 0 - Day 60
Vitamin D	Maintenance of biochemical parameters within normal serum concentrations of vitamin D (30-100 ng/mL)	Day 0 - Day 60
Calcium	Maintenance of biochemical parameters within normal serum concentrations of Calcium (8.6-10,2 mg/dL)	Day 0 - Day 60
Phosphorus	Maintenance of biochemical parameters within normal serum concentrations of Phosphorus (2.5-4.5 mg/dL)	Day 0 - Day 60
Sodium	Maintenance of biochemical parameters within normal serum concentrations of Sodium (136-145 mmol/L)	Day 0 - Day 60
Potassium	Maintenance of biochemical parameters within normal serum concentrations of Potassium (3.5-5.1 mmol/L)	Day 0 - Day 60
Magnesium	Maintenance of biochemical parameters within normal serum concentrations of Magnesium (1.60-2.60 mg/dL)	Day 0 - Day 60
Chlorine	Maintenance of biochemical parameters within normal serum concentrations of Chlorine (99-109 mmol/L)	Day 0 - Day 60
Folic Acid	Maintenance of biochemical parameters within normal serum concentrations of Folic Acid (>2,6 ng/dL)	Day 0 - Day 60
Vitamin B12	Maintenance of biochemical parameters within normal serum concentrations of Vitamin B12 (211-911 pg/mL).	Day 0 - Day 60
Interleukins	Changes in inflammatory m. These biomarkers are measured in pg/mL	Day 0 - Day 60
C-reactive protein (CRP)	Modifications in the C-reactive protein (CRP). This biomarker is measured in mg/L	Day 0 - Day 60
Body weight	Changes produced in body weight measured in kilograms	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.	Day 0 - Day 60
Body mass index (BMI)	Relationship between body weight (kg) and height (m) squared of the individual: Weight/(Height)2	Day 0 - Day 60
Fat mass percentage	Changes or maintenance of the fat mass % measured by electrical bioimpedance	Day 0 - Day 60
Muscle Mass percentage	Changes or maintenance of the muscle mass % measured by electrical bioimpedance	Day 0 - Day 60
Blood pressure	Maintenance in systolic pressure and diastolic pressure measured by blood pressure monitor	Day 0 - Day 60
Heart rate	Heart rate maintenance measured in beats per minute (bpm) using blood pressure monitor	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.	Day 0 - Day 60
Visceral sensitivity	Changes in Visceral Sensitivity Index (VSI) score (Range: 15-90). A lower score means an undesirable visceral sensitivity.	Day 0- Day 60
Zonulin concentration	Changes in fecal zonulin concentration, as a biomarker related to increased intestinal permeability	Day 0 - Day 60
Faecal microbiome analysis	Changes in feacal microbiome after heat treated postbiotic	Day 0 vs Day 60

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Collaborators: Biopolis S.L.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HULP 6010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No