Probiotics and Antibiotic Associated Diarrhea in Pediatric Complicated Appendicitis

Appendicitis Clinical Trial

Official title:

Probiotics and Antibiotic Associated Diarrhea in Pediatric Complicated Appendicitis: Prospective Controlled-Comparison Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04529980
• Other study ID #: STU-2019-0802
• Status: Completed
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: June 2022
• Source: Children's Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

Appendicitis is the most common urgent surgical procedure performed on children. Approximately one third of the population end up having complicated appendicitis with evidence of peritoneal contamination and infection or abscess requiring the use of IV antibiotics and prolonged hospital stay. Antibiotic Associated Diarrhea (AAD) is a common complication seen in both outpatient and inpatient settings in approximately a third of all patients treated with antibiotics (Mantegazza, et al., 2018). In particular, pediatric patients experience ADD 11-62% of the time and can up upwards to 80% in hospitalized toddlers (Mantegazza, et al., 2018). Current literature defines AAD as three or more liquid stools per day. The causes of AAD are often related to the use of multiple antibiotics, prolonged hospital stay and gastrointestinal surgery. Antibiotics often disturb the normal enteric microbiome in the gut and allow for an increased growth of pathogens (Hojsak, 2017). AAD can occur as late as six to eight weeks after antibiotic exposure. 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.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.At Children's Medical Center, the investigators see over 1000 cases of appendicitis a year with approximately 1/3 of those patients being complicated appendicitis. For those requiring immediate appendectomy, the typical course of treatment include surgery, admission to the hospital for 3 to 5 days, administration of IV antibiotics while in hospital, and discharge orders for oral antibiotics to complete their treatment. The investigators propose to perform a randomized controlled trial where one group of patients will receive probiotic therapy and another group of patients does not. The investigators hypothesize patients given probiotics after a diagnosis of complicated appendicitis with immediate appendectomy who receive antibiotic treatment during their inpatient stay will decrease the overall length of stay (LOS) by 25% vs the LOS in those patients who do not receive probiotics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Patients with a post-operative diagnosis of complicated appendicitis who undergo an immediate appendectomy.

2. Patients between the ages of 4 and 18 years of age.

Exclusion Criteria:

1. Patients diagnosed with an complicated appendicitis with deferred appendectomy or non-perforated appendicitis

2. Patients that have a history of being immunosuppressed, on immunosuppression therapy, or long-term steroid therapy within the last month.

3. Patients that have central line access.

4. Patients under 4 years of age.

5. Patients that are developmentally delayed and cannot ambulate at baseline.

6. Patients with significant past medical history.

7. Patients that are in Child Protective Services custody.

8. Patients that are incarcerated.

9. Patients that are pregnant.

10. Patients that speak languages other than English and Spanish.

Related Conditions & MeSH terms

• Appendicitis
• Appendicitis; Perforation
• Diarrhea

Intervention

Dietary Supplement:
• Lactobacillus rhamnosus GG (LGG) Probiotic
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.
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Children's Health Children's Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Children's Health

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Hospital Stay	Length of hospital stay measured in hours from admission to discharge.	Through study completion, an average 1 year
Secondary	Number of diarrhea episodes daily	Documented number of diarrhea episodes each day in EHR.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary	Number of times patient ambulated each day	Documented number of times patient ambulated each day in EHR.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

External Links

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