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Trial record 63 of 121 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

Brief Summary:
The proposed study represents the first attempt to systematically investigate the use of DCS as an adjunct to behavioral intervention to address chronic food aversion through an randomized control drug trial in children treated at the Marcus Autism Center's Pediatrics Feeding Disorders Program. This pilot and feasibility study will involve a total of 16 participants randomly assigned to experimental conditions: behavioral intervention or behavioral intervention + DCS (8 in each group). All participants will receive the same behavioral protocol involving three treatment sessions per day (45 minutes in length), for a total of 15 sessions across five consecutive days. In addition, participants in the behavioral intervention + DCS group will receive a low dose (0.7 mg/kg) of the drug using an acute dosing methodology, which has been demonstrated to produce a nearly negligible side effect profile with comparable treatment outcomes to chronic dosing. Timing of dosing will occur 1 hour prior to behavioral intervention, in line with prior clinical studies. Study staff, with consultation from a psychiatrist, will observe administration of DCS to participants by caregivers via their preferred method of formula consumption (bottle, cup, or tube) in liquid form. Participants will be evaluated during each treatment session and at follow-up using trained observers to collect data on mealtime behaviors, including acceptance, swallowing, disruption, expulsion, and grams consumed. This type of data collection is standard practice in the feeding disorders program. It is hypothesized that participants who receive DCS as an adjunct to behavioral intervention will show greater improvement in mealtime behaviors as reflected by these measures.

Condition or disease Intervention/treatment Phase
Feeding Disorders Specific Phobia Behavioral: Behavioral Intervention Drug: d-cycloserine (DCS) Drug: Placebo Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of D-cycloserine to Facilitate Extinction of Food Aversion in Pediatric Populations
Study Start Date : March 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine

Arm Intervention/treatment
Experimental: Behavioral Intervention & DCS
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: Behavioral Intervention
Behavioral intervention targeting severe feeding disorders involves the combination of escape extinction and antecedent manipulation of food presentation to lessen the aversive quality of the meal. This allows treatment to address the consequences maintaining food refusal in the least restrictive environment while ameliorating possible side effects associated with extinction procedures.

Drug: d-cycloserine (DCS)
Active Comparator: Behavioral Intervention & Placebo
Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube)
Behavioral: Behavioral Intervention
Behavioral intervention targeting severe feeding disorders involves the combination of escape extinction and antecedent manipulation of food presentation to lessen the aversive quality of the meal. This allows treatment to address the consequences maintaining food refusal in the least restrictive environment while ameliorating possible side effects associated with extinction procedures.

Drug: Placebo
lactose powder




Primary Outcome Measures :
  1. Rapid Swallowing [ Time Frame: Mealtime behavior (swallowing) at meal 1 ]
    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).

  2. Rapid Swallowing [ Time Frame: Mealtime behavior (swallowing) at meal 13 ]
    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).

  3. Disruptions [ Time Frame: Mealtime behavior (disruptions) at meal 1 ]
    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

  4. Disruptions [ Time Frame: Mealtime behavior (disruptions) at meal 13 ]
    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



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Ages Eligible for Study:   18 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Present with partial food refusal as evidenced by greater than 50% of caloric needs met by bottle, formula, or tube feedings, thus eliminating children whose lack of consumption is related to a skill deficit
  • Have a medical history significant for an organic factor (e.g., gastrointestinal issues) which precipitated or played a role in the development of feeding concerns, thus capturing children whose food aversion mimics animal and human models of anxiety and aversion
  • Between the ages of 18 months and 6 years
  • Live within 2 hours of the Feeding Disorders Program at Marcus Autism Center to increase retention and maximize attendance
  • English speaking

Exclusion Criteria:

  • Patients with previous behavioral treatment for feeding disorder
  • Patients with active medical conditions requiring ongoing hospitalization
  • Patients unwilling to take study medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923896


Locations
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United States, Georgia
Marcus Autism Center - Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: William G Sharp, Ph.D. Emory University

Additional Information:
Publications:
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Responsible Party: William Sharp, PhD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01923896     History of Changes
Other Study ID Numbers: IRB00061465
DCS-2012-Marcus ( Other Identifier: Other )
First Posted: August 16, 2013    Key Record Dates
Results First Posted: October 23, 2014
Last Update Posted: October 23, 2014
Last Verified: October 2014

Keywords provided by William Sharp, PhD, Emory University:
food refusal
behavioral intervention
D-cycloserine

Additional relevant MeSH terms:
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Cycloserine
Antibiotics, Antitubercular
Anti-Bacterial Agents
Feeding and Eating Disorders
Mental Disorders
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action