Effectiveness of Probiotics Stabilized With Cryoprotection Technology in Patients With Irritable Bowel Syndrome

NCT04206410 | Completed

• 1 other identifier: 6/KBE/2018
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable bowel syndrome (IBS) is one of the most common diseases of the digestive tract in adults, which pathogenesis is not fully understood. It is assumed that intestinal dysbiosis affecting the functioning of the gut-brain axis may be important. Probiotics are live microorganisms that, when administered at the right dose, have a positive effect on human health. Probiotic mechanism of action is related to the modulation of intestinal microbiota. Clinical studies confirm that probiotics administered to patients with IBS have positive health effects. Clinical effects depend primarily on the selection of probiotic strains, but no less important is their viability and stability in the preparation administered to patients. Unfortunately, obtaining stability (a strictly defined number of live probiotic strains in the preparation throughout the shelf life of the preparation) is very technologically difficult. As shown by the audit of the Polish Supreme Audit Office (NIK), almost 90% of probiotics sold on the Polish market do not meet these criteria. There were probiotic preparations that by the end of their expiration date had less than 100 live bacterial cells from the declared number of about one billion. The only preparations that successfully passed NIK inspections turned out to be preparations in which the technology of double microcapsulation of bacteria was used. New technologies are constantly being sought that increase both the survival of bacterial strains in the preparation and the resistance of the strains to hydrochloric acid and bile, which in turn contributes to delivering the right dose of probiotics to the target site of activity, i.e. the small and large intestine. Recent developed an innovative technology called bacterial cryoprotection, which, compared to traditional lyophilization, leads to an increase in the stability of the bacterial cell wall membranes and protects them against negative factors both external (high temperature, humidity etc.) and internal (gastric acid, bile). Therefore, the purpose of the clinical trial is to assess the effectiveness of cryoprotected probiotics in patients with IBS.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome, probiotics

Outcome Measures

Primary Outcomes (4)

• 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

  Improvement/worsening of global symptoms after 4 and 8 weeks of intervention

• 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 50 points is associated with a clinically meaningful improvement.

  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 interventions

• Changes in Quality of Life (IBS-QOL)

  The IBS-Quality of Life (IBS-QOL) is a 34-item measure assessing the degree to which IBS interferes with patient quality of life. Each item is rated on a 5-point Likert scale, thus yielding a total score that has a theoretical range of 34 to 170, with higher scores indicating worse QOL.

  From baseline at 4 and 8 weeks of intervention

Secondary Outcomes (5)

• Changes in type of stools

  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

• Changes in number of bowel movements per day

  From baseline for 8 weeks of intervention

Other Outcomes (1)

• Changes in serum level of intestinal fatty acid binding protein

  From baseline at 8 weeks of intervention

Study Arms (2)

Probiotic

EXPERIMENTAL

Multistrain probiotic mixture consisting of two Lactobacillus strains (L. rhamnosus and L. acidophilus) and three Bifidobacterium strains (B. longum, B. bifidum and B. lactis) administered for 8 weeks in a dose 1,0E+10/day, 2x sachets/day (5,0E+9/cfu per sachet)

Dietary Supplement: Probiotic

Maltodextrin

PLACEBO COMPARATOR

Placebo - Maltodextrin manufactured with an appearance, taste and packaging (sachets) identical to the probiotic mixture administarted for 8 weeks 2x sachets/day

Dietary Supplement: Maltodextrin

Interventions

Probiotic DIETARY_SUPPLEMENT

Multispecies probiotic mixture administered to patients according to the randomization list

Probiotic

Maltodextrin DIETARY_SUPPLEMENT

Maltodextrin as placebo

Maltodextrin

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and female subjects of Caucasian race
• Age between 16 and 60 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.
• Subjects who have provided freely their own written informed consent.
• Subjects available for the whole study period.
• Diagnosed with diarrhea-predominant irritable bowel syndrome (IBS-D) according to Rome III criteria, i.e. symptoms of recurrent abdominal pain or discomfort\* and a marked change in bowel habit with symptoms experienced on at least three days a week of at least three months within last year. Pain/discomfort is related to a change in the appearance of stool, frequency of stool and improves with defecation.
• \* "Discomfort" means an uncomfortable sensation not described as pain.
• The following subjects will be enrolled in the study:
• with diarrhea-predominant irritable bowel syndrome, i.e., persons, who have at least one stool of type 6 or type 7 in Bristol stool score (BSS) over at least 2 days a week
• with at least moderate form assessed using IBS-SSS (5 questions, maximum number of points 500); enrolled subjects with score \>175 points Mild \<175 points, Moderate 175-300 points, Severe \>300 points.
• Subjects 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,

You may not qualify if:

• Patients with cardiovascular disorders: uncontrolled hypertension (blood pressure \> 170/100 mmHg), cerebrovascular diseases.
• Patients with respiratory disorders (asthma, chronic obstructive pulmonary disease \[COPD\]).
• Patients with hepatic disorders (including condition following cholecystectomy procedure) and renal disorders as well as abnormal results of biochemical blood tests without diagnosis: serum creatinine \> 2 x upper limit of normal, AST or ALT \> 2 x upper limit of normal.
• Patients with gastrointestinal disorders other than IBS, including clinically or endoscopic-confirmed gastroenteritis.
• Patients with endocrinological disorders, including patients with diabetes mellitus (fasting blood glucose concentration \> 11 mmol/L), and TSH \> normal.
• Patients with serious neurological disorders, psychosis.
• Patients with malignancies.
• Pregnant or lactating women.
• Soy hypersensitivity.
• The subject has been diagnosed with lactose intolerance and this can explain their symptoms (i.e., symptoms resolved or reduced significantly with lactose-free diet).
• Use of motility drugs or dietary fiber supplements within 2 weeks before study start.
• Patients, taking anti-coagulant medication.
• Plan to have surgery during the time of the study.
• Currently consuming probiotics and refuse to have a three months washout period.
• Recent antibiotic therapy within the last 3 month.

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, Kosikowski W, Szczerbinski M, Gantzel J, Cukrowska B. The Effectiveness of Synbiotic Preparation Containing Lactobacillus and Bifidobacterium Probiotic Strains and Short Chain Fructooligosaccharides in Patients with Diarrhea Predominant Irritable Bowel Syndrome-A Randomized Double-Blind, Placebo-Controlled Study. Nutrients. 2020 Jul 5;12(7):1999. doi: 10.3390/nu12071999.

  PMID: 32635661 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Probiotics; maltodextrin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Bożena Cukrowska, PhD MD

  The Children's Memorial Health Institute

  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: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 20, 2019
• Study Start: September 1, 2018
• Primary Completion: September 10, 2019
• Study Completion: December 10, 2019
• Last Updated: February 3, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)