Trial Outcomes & Findings for Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children (NCT NCT01044030)

NCT ID: NCT01044030

Last Updated: 2018-06-20

Results Overview

Proportion of subjects who remained free of acute otitis media throughout the study period

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 326 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2018-06-20

Participant Flow

Participant milestones

Measure	Xylitol Syrup Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily	Placebo Placebo: 7.5 mL by mouth three times daily
Overall Study STARTED	160	166
Overall Study COMPLETED	141	146
Overall Study NOT COMPLETED	19	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children

Baseline characteristics by cohort

Measure	Xylitol Syrup n=160 Participants Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily	Placebo n=166 Participants Placebo: 7.5 mL by mouth three times daily	Total n=326 Participants Total of all reporting groups
Age, Continuous	22.3 months STANDARD_DEVIATION 13.7 • n=5 Participants	21.5 months STANDARD_DEVIATION 13.7 • n=7 Participants	21.9 months STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	73 Participants n=7 Participants	140 Participants n=5 Participants
Sex: Female, Male Male	93 Participants n=5 Participants	93 Participants n=7 Participants	186 Participants n=5 Participants
Race/Ethnicity, Customized White, non-Hispanic	110 participants n=5 Participants	114 participants n=7 Participants	224 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	25 participants n=5 Participants	22 participants n=7 Participants	47 participants n=5 Participants
Race/Ethnicity, Customized Black, non-Hispanic	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants
Race/Ethnicity, Customized Other/Refused/unknown	18 participants n=5 Participants	22 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Proportion of subjects who remained free of acute otitis media throughout the study period

Outcome measures

Measure	Xylitol Syrup n=160 Participants Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily	Placebo n=166 Participants Placebo: 7.5 mL by mouth three times daily
Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media	66.9 percentage of particpants	63.3 percentage of particpants

SECONDARY outcome

Timeframe: 12 weeks

Proportion of subjects with no antibiotic use during the study period

Outcome measures

Measure	Xylitol Syrup n=160 Participants Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily	Placebo n=166 Participants Placebo: 7.5 mL by mouth three times daily
Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media	60.6 percentage of participants	56.0 percentage of participants

SECONDARY outcome

Timeframe: 12 weeks

Population: This outcome measure is limited to those subjects enrolled in the local enrolling sites only.

Proportion of subjects acquiring colonization with Streptococcus pneumoniae and/or nontypeable Haemophilus influenzae among the subset of patients recruited at the local enrolling sites

Outcome measures

Measure	Xylitol Syrup n=23 Participants Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily	Placebo n=20 Participants Placebo: 7.5 mL by mouth three times daily
Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae	30.4 percentage of participants	20.0 percentage of participants

SECONDARY outcome

Timeframe: 12 weeks

Proportion of subjects colonized with antibiotic resistant S. pneumonia after treatment

Outcome measures

Measure	Xylitol Syrup n=17 Participants Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily	Placebo n=14 Participants Placebo: 7.5 mL by mouth three times daily
Antimicrobial Resistance Patterns of Isolates of Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae Cultured From the Oropharynx and/or Nasopharynx of Subjects Treated With Viscous-adherent Xylitol Compared to Placebo. Resistant	5 Participants	6 Participants
Antimicrobial Resistance Patterns of Isolates of Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae Cultured From the Oropharynx and/or Nasopharynx of Subjects Treated With Viscous-adherent Xylitol Compared to Placebo. Sensitive	12 Participants	8 Participants

SECONDARY outcome

Timeframe: 12 weeks

Proportion of subjects colonized with antibiotic resistant nontypeable H. influenzae after treatment

Outcome measures

Measure	Xylitol Syrup n=16 Participants Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily	Placebo n=17 Participants Placebo: 7.5 mL by mouth three times daily
Antimicrobial Resistance Patterns of Isolates of Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae Cultured From the Oropharynx and/or Nasopharynx of Subjects Treated With Viscous-adherent Xylitol Compared to Placebo. Resistant	10 Participants	7 Participants
Antimicrobial Resistance Patterns of Isolates of Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae Cultured From the Oropharynx and/or Nasopharynx of Subjects Treated With Viscous-adherent Xylitol Compared to Placebo. Sensitive	6 Participants	10 Participants

Adverse Events

Xylitol Syrup

Serious events: 4 serious events

Other events: 89 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 93 other events

Deaths: 0 deaths

Serious adverse events

Measure	Xylitol Syrup n=160 participants at risk Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily	Placebo n=166 participants at risk Placebo: 7.5 mL by mouth three times daily
Ear and labyrinth disorders Tympanostomy tube insertion and adenoidectomy	0.62% 1/160	0.00% 0/166
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/160	0.60% 1/166
Gastrointestinal disorders Gastroenteritis	0.62% 1/160	0.00% 0/166
Skin and subcutaneous tissue disorders Abscess	0.62% 1/160	0.00% 0/166
Respiratory, thoracic and mediastinal disorders Pneumonia	0.62% 1/160	0.00% 0/166

Other adverse events

Measure	Xylitol Syrup n=160 participants at risk Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily	Placebo n=166 participants at risk Placebo: 7.5 mL by mouth three times daily
Gastrointestinal disorders Diarrhea	50.0% 80/160	50.6% 84/166
Gastrointestinal disorders Flatulence	20.0% 32/160	21.1% 35/166
Gastrointestinal disorders Abdominal Pain	9.4% 15/160	4.8% 8/166
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	39.4% 63/160	34.9% 58/166

Additional Information

Louis Vernacchio, MD, MSc

Boston Children's Hospital

Phone: 617-919-4283

Email: louis.vernacchio@childrens.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place