search
Back to results

Multi Strain Probiotic Preparation in Patients With Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome With Diarrhea, Effects of Probiotics

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Multi-strain probiotic mixture of four Bifidobacterium, five Lactobacillus and one Streptococcus species or placebo
Maltodextrin
Sponsored by
Children's Memorial Health Institute, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Diarrhea

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • The Children's Memorial Health Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic preparation

Maltodextrin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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: I feel that the symptoms have worsened significantly I feel that the symptoms have moderately worsened I feel that the symptoms have slightly worsened I feel no change I feel a slight improvement I feel moderate improvement I feel significant improvement IBS-GIS score indicates: improvement if is >4 or worsening if is<4, no change if is 4
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.

Secondary Outcome Measures

Changes in type of stools
ype of stool assessed before intervention and then 3 times a week. Type of stools assessed using the Bristol Stool Scale. Bristol Scale is designed to classify faeces into seven groups: type 1-2 indicate constipation, type 3-4 are "normal" stools; type 5-7 indicate diarrhea.
Changes in number of bowel movements per day
Number of bowel movements per day assessed before intervention and then 3 times a week
Changes in severity of pain
The severity of pain assessed before intervention and then 3 times a week using a patient-defined 5 point Linkert scale: point 0 - no pain, and 1-4 the severity of pain with higher scores indicating worse pain
Changes in flatulence
The severity of flatulence assessed before intervention and then 3 times a week using a patient-defined 5 point Linkert scale: point 0 - no flatulence, and points1-4 with higher scores indicating worse flatulence
Changes in feeling of incomplete evacuation of stool
The severity of incomplete evacuation of stool assessed before intervention and then 3 times a week using a patient-defined 5 point Linkert scale: point 0 - no feeling of incomplete evacuation of stool, and points1-4 with higher scores indicating worse feeling of incomplete evacuation of stool
Changes in the occurrence of adverse events
The number and the type of adverse events assessed before intervention and then 3 times a weeks.

Full Information

First Posted
December 9, 2020
Last Updated
December 11, 2020
Sponsor
Children's Memorial Health Institute, Poland
Collaborators
Medical University of Lublin
search

1. Study Identification

Unique Protocol Identification Number
NCT04662957
Brief Title
Multi Strain Probiotic Preparation in Patients With Irritable Bowel Syndrome
Official Title
The Effectiveness of Multi Strain Probiotic Preparation in Patients With Diarrhea Predominant Irritable Bowel Syndrome - Randomized Double Blide Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
November 2, 2019 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Memorial Health Institute, Poland
Collaborators
Medical University of Lublin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Diarrhea, Effects of Probiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic preparation
Arm Type
Experimental
Arm Description
Multi-strain probiotic mixture. The daily dose was five billion (2 capsules/day).
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
Maltodextrin comparable in color, texture and taste to the probiotic mixture (2 capsules/day).
Intervention Type
Dietary Supplement
Intervention Name(s)
Multi-strain probiotic mixture of four Bifidobacterium, five Lactobacillus and one Streptococcus species or placebo
Intervention Description
Oral supplementation with multi-strain probiotic preparation
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
Maltodextrin as placebo
Primary Outcome Measure Information:
Title
Changes in severity of IBS symptoms using IBS Severity Scoring System (IBS-SSS)
Description
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.
Time Frame
From baseline at 4 and 8 weeks of intervention
Title
Improvement or worsening of IBS global symptoms using Global Improvement Scale (IBS-GIS)
Description
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: I feel that the symptoms have worsened significantly I feel that the symptoms have moderately worsened I feel that the symptoms have slightly worsened I feel no change I feel a slight improvement I feel moderate improvement I feel significant improvement IBS-GIS score indicates: improvement if is >4 or worsening if is<4, no change if is 4
Time Frame
From baseline at 4 and 8 weeks of intervention
Title
Changes in adequate relief of IBS symptoms (IBS-AR)
Description
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.
Time Frame
From baseline at 4 and 8 weeks of intervention
Secondary Outcome Measure Information:
Title
Changes in type of stools
Description
ype of stool assessed before intervention and then 3 times a week. Type of stools assessed using the Bristol Stool Scale. Bristol Scale is designed to classify faeces into seven groups: type 1-2 indicate constipation, type 3-4 are "normal" stools; type 5-7 indicate diarrhea.
Time Frame
From baseline for 8 weeks of intervention
Title
Changes in number of bowel movements per day
Description
Number of bowel movements per day assessed before intervention and then 3 times a week
Time Frame
From baseline for 8 weeks of intervention
Title
Changes in severity of pain
Description
The severity of pain assessed before intervention and then 3 times a week using a patient-defined 5 point Linkert scale: point 0 - no pain, and 1-4 the severity of pain with higher scores indicating worse pain
Time Frame
From baseline for 8 weeks of intervention
Title
Changes in flatulence
Description
The severity of flatulence assessed before intervention and then 3 times a week using a patient-defined 5 point Linkert scale: point 0 - no flatulence, and points1-4 with higher scores indicating worse flatulence
Time Frame
From baseline for 8 weeks of intervention
Title
Changes in feeling of incomplete evacuation of stool
Description
The severity of incomplete evacuation of stool assessed before intervention and then 3 times a week using a patient-defined 5 point Linkert scale: point 0 - no feeling of incomplete evacuation of stool, and points1-4 with higher scores indicating worse feeling of incomplete evacuation of stool
Time Frame
From baseline for 8 weeks of intervention
Title
Changes in the occurrence of adverse events
Description
The number and the type of adverse events assessed before intervention and then 3 times a weeks.
Time Frame
From baseline for 8 weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
The Children's Memorial Health Institute
City
Warsaw
ZIP/Postal Code
04-730
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33652763
Citation
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.
Results Reference
derived

Learn more about this trial

Multi Strain Probiotic Preparation in Patients With Irritable Bowel Syndrome

We'll reach out to this number within 24 hrs