Probiotics and Antibiotic Associated Diarrhea in Pediatric Complicated Appendicitis

NCT04529980 | Completed Results

• 1 other identifier: STU-2019-0802
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effectiveness of the use of probiotics in patients with a diagnosis of complicated appendicitis on antibiotic associated diarrhea (AAD). Probiotics are defined as live microbial organisms that when administered in sufficient amounts, can provide a protective benefit to the individual patient. The use of probiotics in a pediatric population exposed to antibiotics and gastrointestinal surgery such as an appendectomy may provide a protective effect and prevent antibiotic associated diarrhea (ADD)

Conditions

Appendicitis; Appendicitis; Perforation

Keywords

Appendicitis; Probiotics

Outcome Measures

Primary Outcomes (1)

• Length of Hospital Stay

  Length of hospital stay measured in hours from admission to discharge. from admission to discharge, up to 1 month

  From admission to discharge, up to 1 month

Secondary Outcomes (1)

• Number of Diarrhea Episodes Daily

  up to 1 month

Study Arms (2)

Lactobacillus rhanmosus GG(LGG®) Group

EXPERIMENTAL

Lactobacillus rhanmosus GG(LGG®)(Culturelle) is an over the counter dietary supplement that can help to restore the balance in the gut by promoting colonization to support better digestion and immune health. As such, this dietary supplement is not reviewed and approved by the FDA. This study does not intend to investigate route of administration, dose, patient population, or other factor that significantly increases the risk (or decreases the acceptability of the risk) associated with the use of the dietary supplement. Patients in the treatment group will receive a standard dose of Lactobacillus rhamnosus GG capsule following their surgery while in the hospital until discharge.

Dietary Supplement: Lactobacillus rhamnosus GG (LGG) Probiotic

Placebo Control Group

PLACEBO COMPARATOR

Patients in the placebo group will receive a placebo capsule following their surgery while in the hospital until discharge.

Dietary Supplement: Placebo

Interventions

Lactobacillus rhamnosus GG (LGG) Probiotic DIETARY_SUPPLEMENT

Lactobacillus rhanmosus GG(LGG®)(Culturelle) is an over the counter dietary supplement that can help to restore the balance in the gut by promoting colonization to support better digestion and immune health.

Also known as: Culturelle Probiotics Digestive Health

Lactobacillus rhanmosus GG(LGG®) Group

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo Control Group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with a post-operative diagnosis of complicated appendicitis who undergo an immediate appendectomy.
• Patients between the ages of 4 and 18 years of age.

You may not qualify if:

• Patients diagnosed with an complicated appendicitis with deferred appendectomy or non-perforated appendicitis
• Patients that have a history of being immunosuppressed, on immunosuppression therapy, or long-term steroid therapy within the last month.
• Patients that have central line access.
• Patients under 4 years of age.
• Patients that are developmentally delayed and cannot ambulate at baseline.
• Patients with significant past medical history.
• Patients that are in Child Protective Services custody.
• Patients that are incarcerated.
• Patients that are pregnant.
• Patients that speak languages other than English and Spanish.

Sponsors & Collaborators

• Children's Health: lead

Study Sites (1)

Children's Health Children's Medical Center

Dallas, Texas, 75235, United States

Location

Related Publications (6)

• Agamennone V, Krul CAM, Rijkers G, Kort R. A practical guide for probiotics applied to the case of antibiotic-associated diarrhea in The Netherlands. BMC Gastroenterol. 2018 Aug 6;18(1):103. doi: 10.1186/s12876-018-0831-x.

  PMID: 30078376 BACKGROUND

• Bethel M. Probiotics for the prevention of pediatric antibiotic-associated diarrhea: Summary of a Cochrane review. Explore (NY). 2019 Sep-Oct;15(5):382-383. doi: 10.1016/j.explore.2019.07.001. Epub 2019 Jul 11. No abstract available.

  PMID: 31377301 BACKGROUND

• Hayes SR, Vargas AJ. Probiotics for the Prevention of Pediatric Antibiotic-Associated Diarrhea. Explore (NY). 2016 Nov-Dec;12(6):463-466. doi: 10.1016/j.explore.2016.08.015. Epub 2016 Aug 26.

  PMID: 27688016 BACKGROUND

• Hojsak I. Probiotics in Children: What Is the Evidence? Pediatr Gastroenterol Hepatol Nutr. 2017 Sep;20(3):139-146. doi: 10.5223/pghn.2017.20.3.139. Epub 2017 Sep 26.

  PMID: 29026729 BACKGROUND

• Mantegazza C, Molinari P, D'Auria E, Sonnino M, Morelli L, Zuccotti GV. Probiotics and antibiotic-associated diarrhea in children: A review and new evidence on Lactobacillus rhamnosus GG during and after antibiotic treatment. Pharmacol Res. 2018 Feb;128:63-72. doi: 10.1016/j.phrs.2017.08.001. Epub 2017 Aug 19.

  PMID: 28827186 BACKGROUND

• Szajewska H, Kolodziej M. Systematic review with meta-analysis: Lactobacillus rhamnosus GG in the prevention of antibiotic-associated diarrhoea in children and adults. Aliment Pharmacol Ther. 2015 Nov;42(10):1149-57. doi: 10.1111/apt.13404. Epub 2015 Sep 13.

  PMID: 26365389 BACKGROUND

Related Links

• Wanke, M. \& Szajewska, H. (2014). Probiotics for preventing healthcare-associated diarrhea in

MeSH Terms

Conditions

Appendicitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

1\. Data was pulled from documentation in the electronic medical record with the potential for missing documentation.

Results Point of Contact

• Title: Dr. Mayra Garcia, DNP, APRN, PCNS-BC, EBP-C
• Organization: Children's Health Children's Medical Center

Mayra.Garcia@childrens.com

12144567990

Study Officials

• Mayra Garcia, APRN, CNS

  Children's Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients will be randomized into two study groups using randomization and utilizing a sealed envelope randomization plan. Both the care providers and study participants (parents/LAR) will be masked from which treatment assignment the participant was randomized to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Advance Practice Practitioner, APS Administration

Model Details: Those randomized to the treatment group will be given probiotic therapy until discharge, while those randomized to the placebo group will be given a placebo until discharge.

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 28, 2020
• Study Start: September 8, 2020
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)