The Effect of Lactobacillus Reuteri Probiotic as an Adjunct Treatment for Helicobacter Pylori Infection in Adults

NCT05399862 | Completed

• 1 other identifier: FF-2021-004
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomised, double-blind, placebo-controlled trial involving newly diagnosed Helicobacter pylori (H. pylori) patients. Patients will be prescribed with standard triple therapy for 2 weeks and supplemented with either probiotic (Lactobacillus reuteri DSM 17648) or placebo for 4 weeks. In this study, we are investigating the effect of Lactobacillus reuteri in H. pylori eradication; mainly in improving eradication rate, ameliorating gastrointestinal symptoms and reducing adverse effects of antibiotics. We hypothesised that in H. pylori patients receiving Lactobacillus reuteri as adjunct treatment, there will be an improvement in H. pylori eradication rate as well as reduction of gastrointestinal symptoms and treatment adverse effects.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori, probiotics, Lactobacillus reuteri, Gastrointestinal Symptom Rating Scale, GSRS.

Outcome Measures

Primary Outcomes (1)

• The eradication rate of Helicobacter pylori infection

  Eradication rate of H. pylori is defined as negative urea breath test result (score of less than 50 DPM)

  Urea breath test is assessed at 8 weeks post treatment

Secondary Outcomes (2)

• The improvement of H. pylori associated gastrointestinal symptoms

  GSRS scores of both arms were compared between pre and 8 weeks post treatment

• The improvement of treatment adverse effect

  The treatment adverse effects were evaluated during first and second week of treatement; and further re-evaluated back at 8 weeks post treatment

Study Arms (2)

Group A

ACTIVE COMPARATOR

Patients will be given Lactobacillus reuteri probiotic in addition to standard triple therapy. The probiotic is prepared in a capsule form (200mg each capsule), given as 1 capsule per day after meal for 4 weeks.

Dietary Supplement: Lactobacillus reuteri DSM 17648 probiotic

Group B

PLACEBO COMPARATOR

Placebo used in the study contains corn starch with 0.12% of iron oxide yellow, prepared in indistinguishable capsule form as probiotic,; given as 1 capsule per day after meal for 4 weeks.

Other: Placebo

Interventions

Lactobacillus reuteri DSM 17648 probiotic DIETARY_SUPPLEMENT

Lactobacillus reuteri DSM 17648 is a single-strain probiotic used as adjunct treatment in H.pylori infection

Group A

Placebo OTHER

Placebo capsule with no microbial cell preparation

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-year-old and above
• Confirmed H. pylori diagnosis
• Informed consent to participate in the study

You may not qualify if:

• Any active gastrointestinal disease
• Previous surgical procedures affecting the gastrointestinal tract, e.g., bariatric surgery or gastrectomy
• Pregnancy or breastfeeding women
• Previous allergy to probiotics
• Intake of proton pump inhibitor, H2 antagonist or antibiotics in the past 3 months
• Recent diagnosis of advanced stage of malignancy
• Recent acute gastroenteritis within 4 weeks
• Recent history of traditional medication intake
• Recent failure of first line eradication therapy for H. pylori

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead
• Y.S.P. Industries (M) Sdn. Bhd, Menara LGB, Taman Tun Dr Ismail, 60000 Kuala Lumpur, Malaysia: collaborator

Study Sites (1)

The University of Malaysia Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

Location

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: Dr

Model Details: Randomised, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 1, 2022
• Study Start: December 24, 2020
• Primary Completion: December 23, 2021
• Study Completion: January 10, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

MY (1)