The Efficacy of Single-strain Probiotics in Patients With Irritable Bowel Syndrome

NCT05064930 | Completed

• 1 other identifier: CT/NB/120/2020/PR-SS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable bowel syndrome (IBS) is one of the most common, yet still not fully understood, gastrointestinal disorders in adults. One suspected etiology involves intestinal dysbiosis, i.e. both quantitative and qualitative alterations in intestinal microbiota composition, which affects the gut-brain axis. Probiotics are live microorganisms, which-administered at the right dose-are beneficial for human health; their mechanism of action involves modifying the gut microbiota. Clinical study reports document that probiotic administration is beneficial for patients with IBS. The ultimate clinical effects depend primarily on probiotic strain selection. Our research team evaluated a multi-strain probiotic formulation and a multi-strain synbiotic (a combination of probiotic strains with short-chain prebiotic fructooligosaccharides) formulation as part of two randomized placebo-controlled clinical trials in patients with IBS with predominant diarrhea. The results indicated a beneficial effect of these formulations on the clinical course of IBS assessed with the international IBS symptom severity scale (IBS-SSS), with each of the study formulations exhibiting efficacy in different fields. The formulation composed of a mixture of Bifidobacterium and Lactobacillus strains reduced the levels of pain and improved the quality of life, whereas the synbiotic formulation effectively improved bloating and had a beneficial effect on the general condition of the intestines. A systematic review and meta-analysis published in 2020 showed that high doses of single-strain formulations, particularly those containing Bifidobacterium or Lactobacillus strains, may be more effective in IBS patients. Other reports demonstrated a high efficacy of the new-generation probiotic Bacillus coagulans in IBS. Therefore, the main objective of this research project is to assess the efficacy of single-strain probiotics containing Bifidobacterium lactis or Bacillus coagulans in patients with IBS.

Conditions

Irritable Bowel Syndrome

Keywords

Probiotics

Outcome Measures

Primary Outcomes (2)

• Changes in severity of IBS symptoms using IBS Severity Scoring System (IBS-SSS)

  IBS-SSS is a 5-question survey that asks: 1. the severity of abdominal pain, 2. frequency of abdominal pain, 3. severity of abdominal distention, 4.dissatisfaction with bowel habit, and 5. interference with quality of life over the past 10 days. Subjects respond to each question on a 100-point visual analogue scale. Each of the five question generates a maximum score of 100 point, and total scores can range from 0-500 with higher scores indicating severe symptoms. A decrease of 50 points is associated with a clinically meaningful improvement.

  From baseline at 4, 8, 12 weeks of intervention, and 4 weeks (16 weeks of the study) after intervention

• Improvement of IBS global symptoms using Global Improvement Scale (IBS-GIS)

  IBS-Global Improvement Scale assesses IBS symptoms using a patient-defined 7 point Likert scale ranging from symptoms substantially worse to substantially improved. Patients answer the question "Have you felt any change in the severity of your symptoms over the past 7 days compared to how you felt before the medicine was given? The answers are recorded based on the 7-point scale: 1. = I feel that the symptoms have worsened significantly 2. = I feel that the symptoms have moderately worsened 3. = I feel that the symptoms have slightly worsened 4. = I feel no change 5. = I feel a slight improvement 6. = I feel moderate improvement 7. = I feel significant improvement IBS-GIS score indicates: improvement if is \>4 or worsening if is\<4, no change if is 4

  From baseline at 4, 8, 12 weeks of intervention, and 4 weeks (16 weeks of the study) after intervention

Secondary Outcomes (5)

• Changes in number of stools

  From baseline for 12 weeks of intervention, and for 4 weeks after intervention

• Changes in severity of pain

  From baseline for 12 weeks of intervention, and for 4 weeks after intervention

• Changes in flatulence

  From baseline for 12 weeks of intervention, and for 4 weeks after intervention

• Occurrence of side effects

  From baseline for 12 weeks of intervention

• Changes in type of stools

  From baseline for 12 weeks of intervention, and for 4 weeks after intervention

Study Arms (3)

Bifidobacterium lactis

ACTIVE COMPARATOR

Probiotic formula contains 5x109 Bifidobacterium lactis Nordbiotic™ BI040 colony forming units (CFU)/capsule

Dietary Supplement: Probiotic Bifidobacterium lactis

Bacillus coagulans

ACTIVE COMPARATOR

Probiotic formula contains 2x109 Bacillus coagulans Nordbiotic™BC300 colony forming units (CFU)/capsule

Dietary Supplement: Probiotic Bacillus coagulans

Maltodextrin

PLACEBO COMPARATOR

Maltodextrin (starch hydrolisate) as a compound presents in probiotic formula.

Dietary Supplement: Placebo

Interventions

Probiotic Bifidobacterium lactis DIETARY_SUPPLEMENT

The probiotic will be administered orally over a period of 12 weeks.

Bifidobacterium lactis

Probiotic Bacillus coagulans DIETARY_SUPPLEMENT

The probiotic will be administered orally over a period of 12 weeks.

Bacillus coagulans

Placebo DIETARY_SUPPLEMENT

Maltodextrin as a placebo will be administered orally over a period of 12 weeks. The taste and appearance of the placebo will be similar to those of the probiotic formulation.

Maltodextrin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caucasian males and females;
• Age from 18 to 70 years, inclusive;
• Good physical and mental condition assessed based on the patient's history and physical examination;
• Laboratory test results (blood tests, including blood chemistry and antibody tests; and urinalysis) within the normal limits for the local laboratory or considered clinically insignificant by the study investigator;
• A voluntarily provided written informed consent;
• Being available throughout the duration of the study;
• Patients with IBS diagnosed based on the Rome IV criteria;
• Patients with any form of IBS of at least moderate severity assessed via the IBS-SSS (score \>175).

You may not qualify if:

• Cardiovascular disorders: uncontrolled hypertension (blood pressure \> 170/100 mmHg), cerebrovascular disease;
• Severe respiratory disorders (asthma, chronic obstructive pulmonary disease)
• Liver or kidney disease and unexplained blood chemistry abnormalities: serum creatinine of more than twice the upper limit of normal, serum aminotransferease (AST or ALT) levels more than twice the upper limit of normal;
• Gastrointestinal disorders other than IBS (including gastroenteritis, celiac disease, and bacterial infections or parasitic infestations confirmed either clinically or endoscopically);
• Endocrine disorders, including diabetes (fasting blood glucose \> 11 mmol/L) and serum thyroid stimulating hormone (TSH) levels above normal;
• Severe neurological conditions, with psychosis;
• Malignancy;
• Pregnancy or breastfeeding;
• Hypersensitivity to soy;
• Lactose intolerance that may explain the symptoms (i.e. the symptoms resolve or considerably subside in response to a lactose-free diet);
• The use of gastrointestinal motility stimulants or dietary fiber supplements during the 2 weeks preceding the clinical study;
• The use of antithrombotic agents;
• A surgical procedure scheduled during the course of the clinical study;
• Current probiotic use and refusal to undergo a 3-month washout period;
• Antibiotic therapy within the previous 3 months;

Sponsors & Collaborators

• Nordic Biotic Sp. z o.o.: lead
• Medical University of Lublin: collaborator

Study Sites (1)

Medical University of Lublin

Lublin, Poland

Location

Related Publications (1)

• Skrzydlo-Radomanska B, Prozorow-Krol B, Kurzeja-Miroslaw A, Cichoz-Lach H, Laskowska K, Majsiak E, Bierla JB, Agnieszka S, Cukrowska B. The Efficacy and Safety of Single-Strain Probiotic Formulations Containing Bifidobacterium lactis or Bacillus coagulans in Adult Patients with Irritable Bowel Syndrome-A Randomized Double-Blind Placebo-Controlled Three-Arm Interventional Trial. J Clin Med. 2023 Jul 22;12(14):4838. doi: 10.3390/jcm12144838.

  PMID: 37510953 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Barbara Skrzydło-Radomańska, MD, PhD

  Medical University of Lublin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor, MD, PhD

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: October 1, 2021
• Study Start: September 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: July 7, 2023

Record last verified: 2023-07

Locations

PL (1)