Condition category
Digestive System
Date applied
17/12/2019
Date assigned
20/01/2020
Last edited
11/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Current English summary as of 04/02/2020:
Background and study aims
Indigestion is pain or discomfort in the upper abdomen (dyspepsia). Helicobacter pylori (H. pylori) bacteria can break down the stomach's defense against the acid produced to digest food, allowing the stomach lining to become damaged and may induce an ulcer to form. Helinorm is a new food supplement that may improve recovery from dyspepsia due to H. pylori infection.
This study aims to test the new treatment against placebo.

Who can participate?
Patients aged 18 – 65 years who are suffering from dyspepsia and confirmed H. pylori infection.

What does the study involve?
Participants will be randomly allocated to receive either the dietary food supplement (DFS) ‘HELINORM’ or placebo for 28 days as well as usual treatment. Participants will be asked to fill out questionnaires at the start and end of the therapy as well as provide blood samples for testing.

What are the possible benefits and risks of participating?
Main possible benefits of including investigational product in the eradication treatment scheme are increasing of eradication treatment efficacy and tolerance.
There are no any additional risks (except idiosyncrasy reactions) awaited as the investigational product will be used only as an additional aid in complex eradication treatment during the first stage of study and as the investigational product is a dietary food supplement itself related to probiotic remedies. Only adverse events related to antibiotic treatment can be possible in this study - gastrointestinal reactions, allergic reactions etc.

Where is the study run from?
1. First Moscow State Medical University named after I.M. Sechenov (Sechenov University), Russia
2. Moscow State University of Medicine and Dentistry named after A.I. Evdokimov (Moscow), Russia
3. Research Center ECO-safety LLC, Russia

When is the study starting and how long is it expected to run for?
September 2019 to January 2021

Who is funding the study?
Novozymes (Denmark)

Who is the main contact?
Kirill Bessonov
info@mcrbm.com


Previous English summary:
Background and study aims
Indigestion is pain or discomfort in the upper abdomen (dyspepsia). Helicobacter pylori (H. pylori) bacteria can break down the stomach's defence against the acid it produces to digest food, allowing the stomach lining to become damaged and an ulcer to form. Hellinorm is a new food supplement that may improve recovery from dyspepsia due to H. pylori infection.
This study aims to test the new treatment against placebo.

Who can participate?
Patients aged 18 – 65 years who are suffering from dyspepsia and confirmed H. pylori infection.

What does the study involve?
Participants will be randomly allocated to receive either the dietary food supplement (DFS) ‘HELINORM’ or placebo for 28 days as well as usual treatment. Participants will be asked to fill out questionnaires at the start and end of the therapy as well as provide blood samples for testing.

What are the possible benefits and risks of participating?
Main possible benefits of including investigational product in the eradication treatment scheme are increasing of eradication treatment efficacy and tolerance.
There are no any additional risks (except idiosyncrasy reactions) awaited as the investigational product will be used only as an additional aid in complex eradication treatment during the first stage of study and as the investigational product is a dietary food supplement itself related to probiotic remedies. Only adverse events related to antibiotic treatment can be possible in this study - gastrointestinal reactions, allergic reactions etc.

Where is the study run from?
1. First Moscow State Medical University named after I.M. Sechenov (Sechenov University), Russia
2. Moscow State University of Medicine and Dentistry named after A.I. Evdokimov (Moscow), Russia
3. Research Center ECO-safety LLC, Russia

When is the study starting and how long is it expected to run for?
September 2019 to January 2021

Who is funding the study?
Novozymes, Japan

Who is the main contact?
Kirill Bessonov
info@mcrbm.com

Trial website

Contact information

Type

Public

Primary contact

Mr Kirill Bessonov

ORCID ID

Contact details

136-3-236 Profsoyuznaya Str.
Moscow
117321
Russian Federation
+7 (0)9165959823
info@mcrbm.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

BAD 01/2019

Study information

Scientific title

This multicenter, double-blind, randomized, placebo-controlled clinical evaluation is planned to determine the efficacy and safety of the use of dietary food supplements HELINORM against the background of the standard first-line eradication therapy regimen (ESO + AMO + CLA) on for 14 days followed by the use for 14 days in H. pylori-positive adult patients with functional dyspepsia

Acronym

Study hypothesis

The null hypothesis in this clinical evaluation is that the efficacy of the investigational DSF (dietary food supplement) regarding the primary endpoint will not differ from placebo. An alternative hypothesis is that the efficacy of the investigational DSF regarding the primary endpoint will differ from the placebo group (the minimum detectable differences taking into account the sample size rationale will be 10 %).

Study rationale: The efficacy and safety of the use of dietary food supplements HELINORM including the addition to H. pylori eradication therapy regimen have been demonstrated in a number of clinical trials. However, large Russian trials studying the increase in the efficacy and tolerability of first-line eradication therapy for 14 days with the use of HELINORM among patients with functional dyspepsia and H. pylori infection have not been previously conducted.

Ethics approval

1. Approved 17/07/2019, Local Committee on Ethics at First Moscow State Medical University n.a. Sechenov (8 Trubetskaya Str., 119991 Moscow, Russia; +7 495 622 9706; iec@1msmu.ru and iec@sechenov.ru), ref: n/a
2. Approved 13/06/2019, Local Committee on Ethics at Moscow State Medical and Dentistry University n.a. Evdokimov (37 building 2 Gagarinskiy lane, 119002 Moscow, Russia; +7 916 260 7664; ethicano@yahoo.com), ref n/a
3. Approved 19/09/2019, Committee on Ethic`s Questions at LLC Scientific and Research Center ECO-Safety (65 Yuriy Gagarin avenue, 196143 Saint-Petersburg, Russia; +7 812 500 5203; nic@ecosafety.ru), ref: n/a

Study design

Multicenter double-blind randomized placebo-controlled clinical evaluation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request participant information sheet.

Condition

Сonfirmed diagnosis of functional dyspepsia according to Rome IV criteria and presence of H. pylori infection according to 13C-UBT

Intervention

Investigational products: Investigational dietary food supplement (DFS): HELINORM 324 mg capsules for oral administration. Dosage regimen: for adults: 1 capsule BID with meals. Duration of administration is 28 days.
Placebo: capsules for oral administration, completely identical to the investigational DFS HELINORM in appearance, taste and odor. Pure corn maltodextrin (without L. reuteri cells) will be used instead of Pylopass™. Dosage regimen: 1 capsule BID with meals for 28 days.
Concomitant therapy: standard 3-component eradication scheme: Esomeprazole 20 mg film-coated tablets, dosage regimen: 1 tablet BID before meals for 14 days.
Amoxicillin 1000 mg tablets, dosage regimen: 1 tablet BID after meals for 14 days.
Clarithromycin 500 mg tablets, dosage regimen: 1 tablet BID after meals for 14 days.
All subjects are randomized through IWRS.

Subjects examination: Before starting a clinical evaluation, 13C-labeled urea breath test (13C-UBT) will be performed for all patients (visit 1, screening). After inclusion in the study (Visit 2, Day 0) before taking the investigational DFS or placebo and medicinal products for eradication therapy (Stage I), all patients will fill out questionnaires (Questionnaire for dynamic assessment of symptoms of functional gastrointestinal disorders 7 × 7, Gastrointestinal Symptom Rating Scale, Quality of life questionnaire SF-36 (The Short Form-36)).

After the first stage of the clinical study is completed, patients will again be asked to fill out questionnaires (Visit 3, day 14 ± 2). Then the second stage of the clinical study will start (Stage II) when the patients will only take the investigational DFS or placebo for 14 days. It will be followed by a follow-up period of 4 weeks. At the end of the follow-up period (Visit 4, day 56 ± 3), 13C-UBT will be performed for all patients, and patients will fill out questionnaires (Questionnaire for dynamic assessment of symptoms of functional gastrointestinal disorders 7 × 7, Gastrointestinal Symptom Rating Scale, Quality of life questionnaire SF-36 (The Short Form-36)). All patients will fill out a diary throughout the clinical evaluation where they will indicate the date and frequency of administration of the investigational DFS or placebo and medicinal products for eradication therapy. 13C-UBT results, data from questionnaires and diary will be transferred in eCRF. Efficacy evaluation will be carried out after the completion of the follow-up period for all patients who completed the clinical evaluation per protocol.

At Visits 1 and 3 CBC and Blood chemistry will be performed for all subjects. Also for all subjects during the screening period (Visit 1) before randomization Esophagogastroduodenoscopy will be performed.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

Presence and Absence of H. pylori will be confirmed by 13C-UBT test at Visit 1 (Screening) and Visit 4 (End of study)

Secondary outcome measures

Current secondary outcome measures as of 11/02/2020:
1. Subjective evaluation of main disease (functional dyspepsia) will be performed using 7×7 and GSRS scores questionnaires at Visits 2 (Day 0, Start of Treatment), 3 (Day 14, End of Eradication treatment) and 4 (End of study)
2. Quality of life will be assessed using SF-36 questionnaire at Visits 2, 3 and 4
3. Adherence assessed using participant diary during each study visit (Visit 2, Visit 3 and Visit 4)
4. Adverse events (AEs) and serious adverse events (SAEs) assessed by asking the participants and recording them in the AE/SAE log during each study visit (Visit 2, Visit 3 and Visit 4)

Previous secondary outcome measures:
The following parameters were selected as secondary efficacy parameters in the clinical evaluation:
1. Subjective evaluation of main disease (functional dispepsia) will be performed using 7×7 and GSRS scores questionnaires at Visits 2 (Day 0, Start of Treatment), 3 (Day 14, End of Eradication treatment) and 4 (End of study)
2. Subjects Quality of Life will be assessed using SF-36 questionnaire at Visits 2, 3 and 4

Overall trial start date

29/03/2019

Overall trial end date

06/01/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Male or female aged 18 to 65
2. For women of childbearing potential: mandatory use of contraceptive methods
3. Confirmed diagnosis of functional dyspepsia according to Rome IV criteria
4. Presence of H. pylori infection according to 13C-UBT
5. Able to understand and willing to complete all protocol details
6. No history of previous eradication therapy at least a year before the screening
7. Signed informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Total number of subjects to be included: 172

Participant exclusion criteria

1. Erosive and ulcerative changes of the gastric and/or duodenal mucosa
2. Cicatricial changes of the gastric and/or duodenal mucosa
3. History of eradication therapy less than 1 year before screening
4. Use of antibiotics and/or bismuth tripotassium dicitrate and/or H2-blockers and/or proton pump inhibitors 30 days before and during the trial (except for treatment according to the protocol)
5. Use of macrolide antibiotics less than 1 year before screening
6. Any severe, decompensated or unstable somatic disease that may affect the clinical evaluation of the investigational product or put the patient at risk
7. Alcohol or drug use
8. Pregnancy, lactation
9. Known sensitivity to any components of the investigational product and to any of the medicinal products prescribed in this trial
10. History of stomach surgery, small intestine resection or pancreas surgery
11. Positive blood test for HIV and/or syphilis and/or HbsAg and/or HCVAb
12. Chronic diarrhea of various etiologies, except for functional diarrhea or IBS with diarrhea
13. Participation in another clinical trial 30 days before and during the trial
14. Use of probiotics, symbiotics, prebiotics for treatment of H. pylori infections and for other reasons 30 days before the start of trial

Recruitment start date

23/09/2019

Recruitment end date

23/09/2020

Locations

Countries of recruitment

Russian Federation

Trial participating centre

First Moscow State Medical University named after I.M. Sechenov (Sechenov University)
Trubetskaya str. 8, bld. 2
Moscow
119991
Russian Federation

Trial participating centre

Moscow State University of Medicine and Dentistry named after A.I. Evdokimov (Moscow)
Delegatskaya str. 20, bld. 1
Moscow
127473
Russian Federation

Trial participating centre

Research Center ECO-safety LLC
Yu. Gagarin Ave. 65
Saint-Petersburg
196143
Russian Federation

Sponsor information

Organisation

Nizhny Novgorod Chemical and Pharmaceutical Plant Joint Stock Company (Nizhpharm JSC)

Sponsor details

Salganskaya str. 7
Nizhny Novgorod
603950
Russian Federation
+7 (831) 278-80-88
med@stada.ru

Sponsor type

Industry

Website

https://www.stada.ru/

Funders

Funder type

Industry

Funder name

Novozymes

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Japan

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

Information regarding investigational products, patent applications, processes, unpublished scientific data, investigator brochures and other relevant information is confidential and remains the property of the sponsor. Detailed information may only be disclosed to persons involved in the approval or conduct of a clinical evaluation. The investigator may use this information for clinical evaluation purposes only. The investigator shall provide sponsors with all data obtained during the clinical evaluation. The publication of clinical evaluation results is considered in the clinical evaluation agreement (contract).

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Intention to publish date

09/06/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/04/2020: The secondary outcome measures have been changed. 04/02/2020: The following changes have been made: 1. The public title has been changed from "Dietary food supplement Helinorm in eradication treatment of stomach ulcer-causing bacteria H.pylori" to "Dietary food supplement Helinorm containing L.reuteri DSM 17648 in eradication treatment in H.pylori-positive patients with functional dyspepsia". 2. The plain English summary has been changed. 31/12/2019: Trial’s existence confirmed by Local Committee on Ethics at First Moscow State Medical University n.a. Sechenov