Status:

COMPLETED

Probiotic Lozenges for Treatment of Recurrent Aphthous Stomatitis

Lead Sponsor:

Reham Lotfy Aggour

Conditions:

Oral Ulcer

Eligibility:

All Genders

3-45 years

Phase:

NA

Brief Summary

The application of host-modulating bacteria for therapeutic purposes is one of the strongest emerging fields. Probiotics are live microorganisms, which, when administered in an adequate amount, confer...

Detailed Description

The study aimed to explore the effectiveness of probiotics in the treatment of minor recurrent aphthous stomatitis (RAS). We performed a randomized, controlled clinical study. Sixty adult (group A) an...

Eligibility Criteria

Inclusion

  • Males and females aged 18-45 years old, 2. Patients presenting with RAS with the following characteristics: a. Minor aphthous ulcers less than 48 hours' duration prior to enrolment, b. Size no greater than 10 mm in diameter, c. A history that ulcers normally more than 5 days to resolve without treatment. The inclusion criteria for group B is the same except age, children with RAS aged between 3 and 12 years were recruited for the study.

Exclusion

  • A known history of hypersensitivities, immunologic or systemic diseases, pregnancy, smoking,
  • treatment with systemic steroid or other immunomodulatory agents within 1 month before the study
  • use of nonsteroidal anti-inflammatory drugs or oral antihistamines within 1 month prior to the study
  • treatment of the ulcer with any preparation or medication within 72 hours prior to the study
  • treatment with systemic antibiotics within 2 weeks prior to the study and a history of adverse reactions to lactose or fermented milk products.
  • Children with a positive family history of RAS were excluded.

Key Trial Info

Start Date :

December 1 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 21 2019

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT04383236

Start Date

December 1 2016

End Date

April 21 2019

Last Update

May 12 2020

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