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NCT Number: NCT04662957

Multi Strain Probiotic Preparation in Patients With Irritable Bowel Syndrome

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).

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Key information

Conditions

Irritable Bowel Syndrome With Diarrhea Effects of Probiotics

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Memorial Health Institute

Warsaw, 04-730, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

Oral supplementation with multi-strain probiotic preparation

Maltodextrin

Dietary Supplement

Maltodextrin as placebo

Primary outcomes

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

    Time frame: From baseline at 4 and 8 weeks of intervention

    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.

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

    Time frame: From baseline at 4 and 8 weeks of intervention

    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

  3. Changes in adequate relief of IBS symptoms (IBS-AR)

    Time frame: From baseline at 4 and 8 weeks of intervention

    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 outcomes

  1. Changes in type of stools

    Time frame: From baseline for 8 weeks of intervention

    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.

  2. Changes in number of bowel movements per day

    Time frame: From baseline for 8 weeks of intervention

    Number of bowel movements per day assessed before intervention and then 3 times a week

  3. Changes in severity of pain

    Time frame: From baseline for 8 weeks of intervention

    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

  4. Changes in flatulence

    Time frame: From baseline for 8 weeks of intervention

    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

  5. Changes in feeling of incomplete evacuation of stool

    Time frame: From baseline for 8 weeks of intervention

    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

  6. Changes in the occurrence of adverse events

    Time frame: From baseline for 8 weeks of intervention

    The number and the type of adverse events assessed before intervention and then 3 times a weeks.

Sponsors and collaborators

Lead sponsor

Children's Memorial Health Institute, Poland

Other

Collaborators

  • Medical University of Lublin

Registry information

Official study title

The Effectiveness of Multi Strain Probiotic Preparation in Patients With Diarrhea Predominant Irritable Bowel Syndrome - Randomized Double Blide Placebo Controlled Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 10, 2020
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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