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

NCT05367427 | Completed DMC

• 1 other identifier: HULP 6010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy; Gastrointestinal Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (35)

• Frequency of gastrointestinal symptoms

  Day 0 - Day 60

• Gastrointestinal quality of life

  Day 0 - Day 60

• Defecation pattern

  Day 0-Day 60

• Visceral sensitivity

  Day 0- Day 60

• Zonulin concentration

  Day 0 - Day 60

Study Arms (2)

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)

Dietary Supplement: Heat treated postbiotic Bifidobacterium Longum consumption

Placebo

PLACEBO COMPARATOR

Consumption of 2 placebo capsules/day filled with maltodextrin

Dietary Supplement: Placebo

Interventions

Heat treated postbiotic Bifidobacterium Longum consumption DIETARY_SUPPLEMENT

Regular consumption in breakfast of heat treated postbiotic B. longum

Also known as: Experimental

Heat treated postbiotic Bifidobacterium Longum

Placebo DIETARY_SUPPLEMENT

Maltodextrin

Also known as: Control

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead
• Biopolis S.L.: collaborator

Study Sites (1)

Institute for Health Research IdiPAZ

Madrid, 28046, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The masking of the study will be achieved through the identical presentation and characteristics of the product to be consumed. The principal investigator will supply the participants with both the experimental product and the placebo, depending on the randomization. Randomization will be done blindly, so that the participants and the researcher will not know which treatment has been assigned (Experimental or Placebo). Six codes have been generated, 3 for each arm (arm 1: 2325, 2329, 2324; arm 2: 2338, 2333, 2331). The unmasking will take place at the end of the experimental period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel, randomized, double-blind, controlled pilot clinical trial

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: May 10, 2022
• Study Start: February 1, 2022
• Primary Completion: July 31, 2022
• Study Completion: October 31, 2022
• Last Updated: August 15, 2024

Record last verified: 2024-06

Locations

ES (1)