Trial Outcomes & Findings for Inulin and S. Salivarius Reduce Halitosis (NCT NCT02794766)
NCT ID: NCT02794766
Last Updated: 2020-08-19
Results Overview
Unabbreviated scale title: Organoleptic test Minimum: 0 Maximum: 5 Higher score means worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Halitosis measured by organoleptic test was performed before and 14 days after the treatments
Results posted on
2020-08-19
Participant Flow
Participant milestones
| Measure |
Inulin+LS
Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion colony forming units (CFU) per oral each 12 hours for 10 days
Inulin+LS: Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
|
L Salivarius
Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
L salivarius: Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
|
Placebo
Placebo 1 gum per oral each 12 hours, for 10 days
Placebo: Placebo 1 gum each 12 hours for 10 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inulin and S. Salivarius Reduce Halitosis
Baseline characteristics by cohort
| Measure |
Inulin+LS
n=15 Participants
Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion colony forming units (CFU) per oral each 12 hours for 10 days
Inulin+LS: Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
|
L Salivarius
n=15 Participants
Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
L salivarius: Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
|
Placebo
n=15 Participants
Placebo 1 gum per oral each 12 hours, for 10 days
Placebo: Placebo 1 gum each 12 hours for 10 days
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Region of Enrollment
Brazil
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
45 participants
n=4 Participants
|
|
Tongue coating (absent = 0; present = levels 1,2 and 3)
|
2 Level of tongue coating
n=5 Participants
|
2 Level of tongue coating
n=7 Participants
|
2 Level of tongue coating
n=5 Participants
|
2 Level of tongue coating
n=4 Participants
|
PRIMARY outcome
Timeframe: Halitosis measured by organoleptic test was performed before and 14 days after the treatmentsPopulation: Patients with oral halitosis associated with tongue coating
Unabbreviated scale title: Organoleptic test Minimum: 0 Maximum: 5 Higher score means worse outcome.
Outcome measures
| Measure |
Inulin+LS
n=15 Participants
Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion colony forming units (CFU) per oral each 12 hours for 10 days
Inulin+LS: Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
|
L Salivarius
n=15 Participants
Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
L salivarius: Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
|
Placebo
n=14 Participants
Placebo 1 gum per oral each 12 hours, for 10 days
Placebo: Placebo 1 gum each 12 hours for 10 days
|
|---|---|---|---|
|
Halitosis Measured by Organoleptic Test
Day 0
|
3.2 score on a scale
Standard Deviation 0.68
|
3.2 score on a scale
Standard Deviation 0.68
|
2.9 score on a scale
Standard Deviation 0.95
|
|
Halitosis Measured by Organoleptic Test
Day 14
|
1.4 score on a scale
Standard Deviation 0.74
|
1.8 score on a scale
Standard Deviation 0.78
|
1.7 score on a scale
Standard Deviation 0.82
|
PRIMARY outcome
Timeframe: Coating index was evaluted before and 14 days after the treatments.Population: Patients with oral halitosis associated with tongue coating
Unabbreviated scale title: Coating index (evaluated by a trained judge during oral examination) Minimum: 0 Maximum: 4 Higher score means worse outcome.
Outcome measures
| Measure |
Inulin+LS
n=15 Participants
Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion colony forming units (CFU) per oral each 12 hours for 10 days
Inulin+LS: Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
|
L Salivarius
n=15 Participants
Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
L salivarius: Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
|
Placebo
n=14 Participants
Placebo 1 gum per oral each 12 hours, for 10 days
Placebo: Placebo 1 gum each 12 hours for 10 days
|
|---|---|---|---|
|
Coating Index
Day 0
|
2.2 score on a scale
Standard Deviation 0.56
|
2.1 score on a scale
Standard Deviation 0.52
|
2.0 score on a scale
Standard Deviation 0.78
|
|
Coating Index
Day 14
|
1.3 score on a scale
Standard Deviation 0.49
|
1.7 score on a scale
Standard Deviation 0.70
|
1.4 score on a scale
Standard Deviation 0.50
|
PRIMARY outcome
Timeframe: Halitosis measured by halimeter test was performed before and 14 days after the treatmentsPopulation: Patients with oral halitosis associated with tongue coating
Unabbreviated scale title: Halitosis measured by halimeter Minimum: 0 Maximum: 500 A score =\>75 ppb means halitosis.
Outcome measures
| Measure |
Inulin+LS
n=15 Participants
Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion colony forming units (CFU) per oral each 12 hours for 10 days
Inulin+LS: Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
|
L Salivarius
n=15 Participants
Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
L salivarius: Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
|
Placebo
n=14 Participants
Placebo 1 gum per oral each 12 hours, for 10 days
Placebo: Placebo 1 gum each 12 hours for 10 days
|
|---|---|---|---|
|
Halitosis Measured by Halimeter
Day 0
|
181 score on a scale
Standard Deviation 93
|
197 score on a scale
Standard Deviation 145
|
187 score on a scale
Standard Deviation 132
|
|
Halitosis Measured by Halimeter
Day 14
|
100 score on a scale
Standard Deviation 55
|
125 score on a scale
Standard Deviation 71
|
149 score on a scale
Standard Deviation 117
|
SECONDARY outcome
Timeframe: Oral health impact profile -14 questionnaire was filled before and 14 days after the treatmentsPopulation: Patients with oral halitosis associated with tongue coating
Unabbreviated scale title: Oral-health related quality of life measured by Oral Health Impact Profile -14 questionnaire Manimum: 0 Maximum: 56 Higher scores mean worse outcome
Outcome measures
| Measure |
Inulin+LS
n=15 Participants
Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion colony forming units (CFU) per oral each 12 hours for 10 days
Inulin+LS: Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
|
L Salivarius
n=15 Participants
Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
L salivarius: Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
|
Placebo
n=14 Participants
Placebo 1 gum per oral each 12 hours, for 10 days
Placebo: Placebo 1 gum each 12 hours for 10 days
|
|---|---|---|---|
|
Oral-health Related Quality of Life
Day 14
|
5.6 score on a scale
Standard Deviation 7.8
|
4.9 score on a scale
Standard Deviation 7.9
|
6.6 score on a scale
Standard Deviation 8.6
|
|
Oral-health Related Quality of Life
Day 0
|
8.8 score on a scale
Standard Deviation 10.6
|
5.7 score on a scale
Standard Deviation 6.9
|
6.7 score on a scale
Standard Deviation 8.8
|
Adverse Events
Inulin+LS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
L Salivarius
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Inulin+LS
n=15 participants at risk
Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion colony forming units (CFU) per oral each 12 hours for 10 days
Inulin+LS: Experimental treatment: A gum of inulin 1g plus Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
|
L Salivarius
n=15 participants at risk
Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
L salivarius: Active comparator: A gum of Lactobacillus salivarius G60 1 billion CFU per oral each 12 hours for 10 days
|
Placebo
n=14 participants at risk
Placebo 1 gum per oral each 12 hours, for 10 days
Placebo: Placebo 1 gum each 12 hours for 10 days
|
|---|---|---|---|
|
Nervous system disorders
headache
|
6.7%
1/15 • Number of events 1 • 10 days
Headache in one patient during 10 days use of Inulin + LS Tongue discomfort in two patients during 10 days use of LS Mild diarrhea in one patient during 10 days use of placebo
|
0.00%
0/15 • 10 days
Headache in one patient during 10 days use of Inulin + LS Tongue discomfort in two patients during 10 days use of LS Mild diarrhea in one patient during 10 days use of placebo
|
0.00%
0/14 • 10 days
Headache in one patient during 10 days use of Inulin + LS Tongue discomfort in two patients during 10 days use of LS Mild diarrhea in one patient during 10 days use of placebo
|
|
Gastrointestinal disorders
tongue discomfort
|
0.00%
0/15 • 10 days
Headache in one patient during 10 days use of Inulin + LS Tongue discomfort in two patients during 10 days use of LS Mild diarrhea in one patient during 10 days use of placebo
|
13.3%
2/15 • Number of events 2 • 10 days
Headache in one patient during 10 days use of Inulin + LS Tongue discomfort in two patients during 10 days use of LS Mild diarrhea in one patient during 10 days use of placebo
|
0.00%
0/14 • 10 days
Headache in one patient during 10 days use of Inulin + LS Tongue discomfort in two patients during 10 days use of LS Mild diarrhea in one patient during 10 days use of placebo
|
|
Gastrointestinal disorders
Mild diarrhea
|
0.00%
0/15 • 10 days
Headache in one patient during 10 days use of Inulin + LS Tongue discomfort in two patients during 10 days use of LS Mild diarrhea in one patient during 10 days use of placebo
|
0.00%
0/15 • 10 days
Headache in one patient during 10 days use of Inulin + LS Tongue discomfort in two patients during 10 days use of LS Mild diarrhea in one patient during 10 days use of placebo
|
7.1%
1/14 • Number of events 1 • 10 days
Headache in one patient during 10 days use of Inulin + LS Tongue discomfort in two patients during 10 days use of LS Mild diarrhea in one patient during 10 days use of placebo
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place