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Trial record 63 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

D-cycloserine and Treatment of Feeding Disorders

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ClinicalTrials.gov Identifier: NCT01923896
Recruitment Status : Completed
First Posted : August 16, 2013
Results First Posted : October 23, 2014
Last Update Posted : October 23, 2014
Sponsor:
Information provided by (Responsible Party):
William Sharp, PhD, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Feeding Disorders
Specific Phobia
Interventions Behavioral: Behavioral Intervention
Drug: d-cycloserine (DCS)
Drug: Placebo
Enrollment 16
Recruitment Details Participants were enrolled beginning in April 2013 through July 2013
Pre-assignment Details  
Arm/Group Title Behavioral Intervention & DCS Behavioral Intervention & Placebo
Hide Arm/Group Description Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day. Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
Period Title: Overall Study
Started 8 8
Completed 7 8
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title Behavioral Intervention & DCS Behavioral Intervention & Placebo Total
Hide Arm/Group Description Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day. Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day. Total of all reporting groups
Overall Number of Baseline Participants 8 8 16
Hide Baseline Analysis Population Description
Sixteen subjects (10 male subjects, 6 female subjects) were randomly assigned to DCS or placebo (Table 1). There were no significant group differences on demographic or clinical measures at baseline. Participants were enrolled beginning in April 2013 through July 2013, with final follow-up visits completed September 2013.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 8 participants 8 participants 16 participants
33.9  (10.1) 32.3  (11.9) 33.1  (10.7)
[1]
Measure Description: Months
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Female
3
  37.5%
3
  37.5%
6
  37.5%
Male
5
  62.5%
5
  62.5%
10
  62.5%
1.Primary Outcome
Title Rapid Swallowing
Hide Description Rapid swallowing was scored if the child swallowed the entire bolus within 30 seconds after the feeder deposited the bite. This was visually confirmed by the feeder using a three-step prompting sequence (i.e., verbal: ‘‘show me’’; gestural: ‘‘show me like this’’ plus modeling opening the mouth; physical: ‘‘show me’’ plus gentle pressure applied to the side of the teeth with a baby spoon).
Time Frame Mealtime behavior (swallowing) at meal 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Intervention & DCS Behavioral Intervention & Placebo
Hide Arm/Group Description:
Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
Overall Number of Participants Analyzed 8 8
Median (Inter-Quartile Range)
Unit of Measure: percentage of bites
18.6
(13.0 to 30.0)
14.3
(8 to 58.8)
2.Primary Outcome
Title Rapid Swallowing
Hide Description Rapid swallowing was scored if the child swallowed the entire bolus within 30 seconds after the feeder deposited the bite. This was visually confirmed by the feeder using a three-step prompting sequence (i.e., verbal: ‘‘show me’’; gestural: ‘‘show me like this’’ plus modeling opening the mouth; physical: ‘‘show me’’ plus gentle pressure applied to the side of the teeth with a baby spoon).
Time Frame Mealtime behavior (swallowing) at meal 13
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects completed up to meal 13.
Arm/Group Title Behavioral Intervention & DCS Behavioral Intervention & Placebo
Hide Arm/Group Description:
Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
Overall Number of Participants Analyzed 8 8
Median (Inter-Quartile Range)
Unit of Measure: percentage of bites
96.3
(82.3 to 100)
88.3
(10.0 to 100)
3.Primary Outcome
Title Disruptions
Hide Description Disruptions were defined as turning the head 45 degrees away from the spoon and/or pushing away the spoon or feeder’s hand/arm during the bite presentation. Converted counts of each variable into percentages by dividing the total occurrence of a target behavior during a meal by the total number of bites presented per meal
Time Frame Mealtime behavior (disruptions) at meal 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Intervention & DCS Behavioral Intervention & Placebo
Hide Arm/Group Description:
Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
Overall Number of Participants Analyzed 8 8
Median (Inter-Quartile Range)
Unit of Measure: percentage of inappropriate behaviors
87.6
(75.7 to 98.8)
84.3
(35.4 to 98.6)
4.Primary Outcome
Title Disruptions
Hide Description Disruptions were defined as turning the head 45 degrees away from the spoon and/or pushing away the spoon or feeder’s hand/arm during the bite presentation. Converted counts of each variable into percentages by dividing the total occurrence of a target behavior during a meal by the total number of bites presented per meal
Time Frame Mealtime behavior (disruptions) at meal 13
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Intervention & DCS Behavioral Intervention & Placebo
Hide Arm/Group Description:
Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
Overall Number of Participants Analyzed 8 8
Median (Inter-Quartile Range)
Unit of Measure: percentage of inappropriate behaviors
13.4
(0 to 40)
15
(1.4 to 48.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Behavioral Intervention & DCS Behavioral Intervention & Placebo
Hide Arm/Group Description Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day. Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
All-Cause Mortality
Behavioral Intervention & DCS Behavioral Intervention & Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Behavioral Intervention & DCS Behavioral Intervention & Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Behavioral Intervention & DCS Behavioral Intervention & Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/8 (12.50%)      0/8 (0.00%)    
Gastrointestinal disorders     
Diarrhea *  1/8 (12.50%)  1 0/8 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
The sample size was small and analyses were underpowered to detect group differences.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: William G. Sharp Ph.D.
Organization: Emory University
Phone: 404-419-5162
Responsible Party: William Sharp, PhD, Emory University
ClinicalTrials.gov Identifier: NCT01923896     History of Changes
Other Study ID Numbers: IRB00061465
DCS-2012-Marcus ( Other Identifier: Other )
First Submitted: September 18, 2012
First Posted: August 16, 2013
Results First Submitted: October 17, 2014
Results First Posted: October 23, 2014
Last Update Posted: October 23, 2014