Multi Strain Probiotic Preparation in Patients With Irritable Bowel Syndrome

NCT04662957 | Completed

• 1 other identifier: MBX02/2019/P
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders characterized by recurrent abdominal pain associated with defecation or a change in bowel habits without any structural abnormalities. Despite extensive research, the pathogenesis of IBS has not been clearly elucidated yet. Recent studies have shown that disturbed gut microbiota may promote the development and maintenance of IBS. Significant changes in the microbial communities of healthy controls vs IBS patients have been reported in several studies. These findings promoted the research on probiotics for the treatment of IBS. Probiotics are live microorganisms which, when administered at the right dose, have a positive effect on human health. The currently published systemic reviews and meta-analyses of randomized clinical trials have indicated that probiotics have beneficial clinical effects and can help to reduce global and specific IBS symptoms significantly. However, the effect depends on the specific composition of the probiotic preparation, and some meta-analyzes indicate that multi-strain preparations are more effective than single-strain preparations. Therefore, further research is highly anticipated. The purpose of the current clinical trial is to assess the effectiveness of multi-strain probiotic preparation in patients with diarrhea predominant IBS (IBS-D).

Conditions

Irritable Bowel Syndrome With Diarrhea; Effects of Probiotics

Outcome Measures

Primary Outcomes (3)

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

  IBS-Severity Scoring System 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 30 points is associated with a clinically meaningful improvement.

  From baseline at 4 and 8 weeks of intervention

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

  IBS-Global Improvement Scale asseses IBS symptoms using a patient-defined 7 point Linkert 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 and 8 weeks of intervention

• Changes in adequate relief of IBS symptoms (IBS-AR)

  IBS-Adequate Relief (IBS-AR) is a dichotomous single item that asks participants "Over the past week (7 days) have you had adequate relief of your IBS symptoms? The answer is YES or NO.

  From baseline at 4 and 8 weeks of intervention

Secondary Outcomes (6)

• Changes in type of stools

  From baseline for 8 weeks of intervention

• Changes in number of bowel movements per day

  From baseline for 8 weeks of intervention

• Changes in severity of pain

  From baseline for 8 weeks of intervention

• Changes in flatulence

  From baseline for 8 weeks of intervention

• Changes in feeling of incomplete evacuation of stool

  From baseline for 8 weeks of intervention

Study Arms (2)

Probiotic preparation

EXPERIMENTAL

Multi-strain probiotic mixture. The daily dose was five billion (2 capsules/day).

Dietary Supplement: Multi-strain probiotic mixture of four Bifidobacterium, five Lactobacillus and one Streptococcus species or placebo

Maltodextrin

PLACEBO COMPARATOR

Maltodextrin comparable in color, texture and taste to the probiotic mixture (2 capsules/day).

Dietary Supplement: Maltodextrin

Interventions

Multi-strain probiotic mixture of four Bifidobacterium, five Lactobacillus and one Streptococcus species or placebo DIETARY_SUPPLEMENT

Oral supplementation with multi-strain probiotic preparation

Probiotic preparation

Maltodextrin DIETARY_SUPPLEMENT

Maltodextrin as placebo

Maltodextrin

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• diarrhea-predominant irritable bowel syndrome (IBS-D)
• at least moderate form of IBS-D assessed using IBS-SSS, i.e. with score \>175
• male and female subjects of Caucasian race
• age between 16 and 70 years (inclusive)
• good physical, medical and mental status estimated on the basis of the medical history and a general clinical examination
• results of laboratory tests (hematology, clinical chemistry, serology, and urinalysis) within the normal range of the local laboratory or considered non-clinically significant by the investigator
• patients who have provided freely their own written informed consent
• patients available for the whole study period
• patients who are able to follow strictly the instructions of the investigational team regarding the study procedures and to fulfil the requirements of the protocol
• the following medications are permitted during the course of the study, as long as they are used at a constant dosage and are commenced at least 1 month prior to study start: birth control pill, or depot intramuscular contraceptive preparation, estrogen-progesterone replacement therapy, L-thyroxine, low-dose antidepressants (up to 25 mg day of amitriptyline, nortriptyline, or selective serotonin reuptake inhibitor), low-dose antihypertensives in the diuretic, angiotensin-converting enzyme inhibitor or angiotensin II inhibitor classes
• patients are allowed to take spasmolytic drugs on an ad hoc basis

You may not qualify if:

• other than IBD-D types of IBD
• mild type of IBS-D (\<175 points in IBS-SSS scale)
• the use of probiotics within last three months
• the treatment with antibiotics within last three months
• a concurrent severe illness (malignancies, uncontrolled hypertension and diabetes mellitus, hepatic, renal or cardiac dysfunctions, serious neurological disorders, psychosis, respiratory disorders such as asthma, chronic obstructive pulmonary disease, hyper- or hypothyroidism)
• chronic bowel disorders other than IBS, including inflammatory bowel diseases, gastroenteritis, stomach and duodenal ulcers, celiac diseases;
• pregnancy or lactation
• diagnosed lactose intolerance
• the use of motility drugs or dietary fiber supplements within 2 weeks before study start
• plan to have surgery during the time of the study
• a history of alcohol or drug abuse
• taking anti-coagulant medications
• participation in another clinical trial within last three months
• patients who will receive antibiotics during the study

Sponsors & Collaborators

• Children's Memorial Health Institute, Poland: lead
• Medical University of Lublin: collaborator

Study Sites (1)

The Children's Memorial Health Institute

Warsaw, 04-730, Poland

Location

Related Publications (1)

• Skrzydlo-Radomanska B, Prozorow-Krol B, Cichoz-Lach H, Majsiak E, Bierla JB, Kanarek E, Sowinska A, Cukrowska B. The Effectiveness and Safety of Multi-Strain Probiotic Preparation in Patients with Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized Controlled Study. Nutrients. 2021 Feb 26;13(3):756. doi: 10.3390/nu13030756.

  PMID: 33652763 DERIVED

MeSH Terms

Interventions

maltodextrin

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: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD, PhD

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 10, 2020
• Study Start: November 2, 2019
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Locations

PL (1)