Does Helipyl Eradicate

Eradication Clinical Trial

— Helipyl  

Official title:

Does Helipyl Eradicate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04618159
• Other study ID #: 2018-380
• Status: Completed
• Phase: Phase 4
• Start date: February 10, 2019
• Est. completion date: January 25, 2020

Study information

• Verified date: November 2020
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Helipyl is on the market; actually it is a post-biotic because it is a killed Lactobacillus reuteri DSMZ 17648. The aim is to demonstrate (or not) that this product eradicates helicobacter, which it claims to do.

Description:

This is a pilot project. There is quite limited literature on this product and Helicobacter pylori eradication. My personal opinion is that the literature and guidelines are contradictory. The European guideline is that Helicobacter pylori should not be corrected unless there are "serious" symptoms . On the other hand, Helicobacter is a carcinogen. Quite often, parents ask us, children's gastroenterologists, to screen their children for Helicobacter because they are symptomatic and are being eradicated, and know that Helicobacter is contagious. This creates a difficult situation: not answering the question is not an option according to the parents' opinion. Going into the question and eradicating "classic" is against all guidelines. Hence this pilot project: 10 complaints-free carriers of Helicobacter pylori (> 5 years) will be treated with Helipyl for one month (product supplied by the company). Beforehand, at the end of the treatment and a month after stopping of the treatment, we do a C13 breath test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 25, 2020
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

• >5 and <18 years
• male and female
• asymptomatic helicobacter pylori

Exclusion Criteria:

• helicobacter pylori infection with symptoms
• <5 years

Related Conditions & MeSH terms

• Eradication

Intervention

Other:
• lactobacillus reuteri DSMZ 17648
to evaluate if this product can eradicate helicobacter pylori

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussels	Brussel Hoofdstedelijk Gewest

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate the C13 breathtest	evaluation of C13 breathtest before, at the end of treatment and one month after treatment	6months