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Probiotics and Antibiotic Associated Diarrhea in Pediatric Complicated Appendicitis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04529980
Enrollment
98
Registered
2020-08-28
Start date
2020-09-08
Completion date
2022-02-28
Last updated
2024-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis, Appendicitis; Perforation

Keywords

Appendicitis, Probiotics

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)

Detailed 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.

Interventions

DIETARY_SUPPLEMENTLactobacillus 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.

DIETARY_SUPPLEMENTPlacebo

Placebo

Sponsors

Children's Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Length of Hospital StayFrom admission to discharge, up to 1 monthLength of hospital stay measured in hours from admission to discharge. from admission to discharge, up to 1 month

Secondary

MeasureTime frameDescription
Number of Diarrhea Episodes Dailyup to 1 monthDocumented number of diarrhea episodes each day in EHR.

Countries

United States

Participant flow

Participants by arm

ArmCount
Lactobacillus Rhanmosus GG(LGG®) Group
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. 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.
53
Placebo Control Group
Patients in the placebo group will receive a placebo capsule following their surgery while in the hospital until discharge. Placebo: Placebo
40
Total93

Baseline characteristics

CharacteristicLactobacillus Rhanmosus GG(LGG®) GroupPlacebo Control GroupTotal
Age, Categorical
<=18 years
53 Participants40 Participants93 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous10.23 years
STANDARD_DEVIATION 3.51
10.53 years
STANDARD_DEVIATION 3.94
10.29 years
STANDARD_DEVIATION 3.65
Ethnicity (NIH/OMB)
Hispanic or Latino
36 Participants29 Participants65 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
16 Participants11 Participants27 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
3 Participants0 Participants3 Participants
Race (NIH/OMB)
Black or African American
4 Participants2 Participants6 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
45 Participants38 Participants83 Participants
Region of Enrollment
United States
53 Participants40 Participants93 Participants
Sex: Female, Male
Female
20 Participants23 Participants43 Participants
Sex: Female, Male
Male
33 Participants17 Participants50 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 530 / 40
other
Total, other adverse events
0 / 530 / 40
serious
Total, serious adverse events
0 / 530 / 40

Outcome results

Primary

Length of Hospital Stay

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

Time frame: From admission to discharge, up to 1 month

ArmMeasureValue (MEAN)Dispersion
Lactobacillus Rhanmosus GG(LGG®) GroupLength of Hospital Stay121.55 hoursStandard Deviation 59.21
Placebo Control GroupLength of Hospital Stay131.69 hoursStandard Deviation 74.27
Secondary

Number of Diarrhea Episodes Daily

Documented number of diarrhea episodes each day in EHR.

Time frame: up to 1 month

ArmMeasureValue (MEAN)Dispersion
Lactobacillus Rhanmosus GG(LGG®) GroupNumber of Diarrhea Episodes Daily12.43 episodes/dayStandard Deviation 15.51
Placebo Control GroupNumber of Diarrhea Episodes Daily9.50 episodes/dayStandard Deviation 11.05

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026