What side effects are associated with this type of intervention?

Treatments for feeding intolerance, such as prebiotics, probiotics, and glycerin suppositories, generally have a good safety profile with few side effects. Prebiotics may theoretically promote the growth of harmful bacteria in preterm infants, but no adverse effects were observed in clinical trials. Glycerin suppositories are being studied for their safety and effectiveness in preventing necrotizing enterocolitis in premature infants, with a focus on feasibility and participation rates.

What prior FDA approvals exist?

The FDA has approved several treatments for feeding intolerance, particularly in premature infants. One notable treatment is glycerin suppositories, which are used to stimulate the digestive tract and potentially prevent necrotizing enterocolitis (NEC). Other related FDA-approved drugs include prokinetic agents like metoclopramide and erythromycin, which enhance gastrointestinal motility. Additionally, probiotics such as Lactobacillus reuteri have been studied for their role in promoting gut health and preventing feeding intolerance and NEC in preterm infants.

What other types of research exist?

Promising novel alternatives to glycerin suppositories for feeding intolerance patients include the use of probiotics such as Lactobacillus reuteri, which has shown efficacy in reducing infantile colic and potentially improving gut health. Additionally, prebiotics like galacto-oligosaccharides (GOS) and fructo-oligosaccharides (FOS) may support beneficial microbiota growth and enhance gut barrier function. These interventions have demonstrated good safety profiles and may help in preventing conditions like necrotizing enterocolitis.

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Glycerin Suppositories for Premature Infants

N/A

Waitlist Available

Led By J M Walton, M.D.

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Gestational age 24-32 weeks OR * Birth weight 500-1500 grams

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial is testing glycerin suppositories in premature babies to help their bowels work better and prevent serious infections. The study will begin with a small group of babies to determine if a larger trial is feasible.

Who is the study for?

This trial is for premature infants born between 24-32 weeks of gestation or those with a birth weight of 500-1500 grams. It aims to help prevent feeding and digestive problems, including a serious bowel infection called necrotizing enterocolitis.

What is being tested?

The study is testing if glycerin suppositories can stimulate the digestive system in premature babies to prevent complications. Babies will be randomly given either a real glycerin suppository or a sham (fake) one as part of the pilot study at McMaster University Medical Centre.

What are the potential side effects?

Potential side effects may include mild discomfort or irritation where the suppository is inserted. Since this is a preliminary study, part of its purpose is to assess safety and any other possible side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Days to complete meconium evacuation

Other study objectives

Completion rate

Recruitment rate

Treatment-related adverse events

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Glycerin SuppositoryActive Control1 Intervention

Group II: Sham SuppositoryPlacebo Group1 Intervention

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Feeding intolerance in neonates, especially preterm infants, can lead to severe complications like necrotizing enterocolitis (NEC). Treatments such as glycerin suppositories stimulate the digestive tract, promoting bowel movements and reducing stasis, which helps in the timely passage of enteral feeds and reduces the risk of bacterial overgrowth and infection. This is crucial for preventing NEC and ensuring better nutrient absorption. Other treatments may include prokinetics to enhance motility and careful management of feeding volumes and schedules to help the immature gut adapt gradually.

Gestational and postnatal maturation of duodenal motor responses to intragastric feeding.Gastrointestinal motility in the neonate.Two weeks of repetitive gut-challenge reduce exercise-associated gastrointestinal symptoms and malabsorption.