AppendicitisNCT04529980
Probiotics and Antibiotic Associated Diarrhea in Pediatric Complicated Appendicitis
A study testing Lactobacillus rhamnosus GG (LGG) Probiotic in people with Appendicitis and Appendicitis; Perforation, run by Children's Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Appendicitis, Appendicitis; Perforation
- What is being tested?
- Lactobacillus rhamnosus GG (LGG) Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2020to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Health Children's Medical Center
Dallas, Texas, 75235
About this study
Official title: Probiotics and Antibiotic Associated Diarrhea in Pediatric Complicated Appendicitis: Prospective Controlled-Comparison Trial
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)
Read the 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.
- Conditions
- Appendicitis, Appendicitis; Perforation
- Being tested
- Lactobacillus rhamnosus GG (LGG) Probiotic, Placebo
- Keywords
- Appendicitis, Probiotics
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosus GG (LGG) ProbioticDietary supplement
Also called Culturelle Probiotics Digestive Health
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.
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay
Length of hospital stay measured in hours from admission to discharge. from admission to discharge, up to 1 month
Measured: From admission to discharge, up to 1 month
Secondary outcomes (1)
Number of Diarrhea Episodes Daily
Documented number of diarrhea episodes each day in EHR.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start8 Sep 2020
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayra Garcia, Children's Health
- Investigators
- Mayra Garcia, APRN, CNS, Principal investigator, Children's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529980
- Sponsor's protocol ID
- STU-2019-0802
- Status last verified
- Aug 2024
- First submitted
- 24 Aug 2020
- Last updated
- 13 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30078376Bethel 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.
PubMed 31377301Hayes 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.
PubMed 27688016Hojsak 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.
PubMed 29026729Mantegazza 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.
PubMed 28827186Szajewska 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.
PubMed 26365389
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics and Antibiotic Associated Diarrhea in Pediatric Complicated Appendicitis: Prospective Controlled-Comparison Trial
- ClinicalTrials.gov ID
- NCT04529980
- Acronym / sponsor ID
- STU-2019-0802
- Conditions
- Appendicitis, Appendicitis; Perforation
- Keywords
- Appendicitis, Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Children's HealthUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Posted 13 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus rhanmosus GG(LGG®) Group | Experimental | Dietary Supplement: Lactobacillus rhamnosus GG (LGG) ProbioticLactobacillus 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. |
| Placebo Control Group | Placebo comparator | Dietary Supplement: PlaceboPatients in the placebo group will receive a placebo capsule following their surgery while in the hospital until discharge. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus rhamnosus GG (LGG) ProbioticAlso: Culturelle Probiotics Digestive HealthLactobacillus 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 supplement | Lactobacillus rhanmosus GG(LGG®) Group |
| PlaceboPlacebo | Dietary supplement | Placebo Control Group |
Primary outcome
Length of Hospital Stay
Time frame: From admission to discharge, up to 1 month
Length of hospital stay measured in hours from admission to discharge. from admission to discharge, up to 1 month
1 secondary outcome
Number of Diarrhea Episodes Daily
Time frame: up to 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30078376Agamennone 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.
- Background: PubMed 31377301Bethel 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.
- Background: PubMed 27688016Hayes 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.
- Background: PubMed 29026729Hojsak 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.
- Background: PubMed 28827186Mantegazza 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.
- Background: PubMed 26365389Szajewska 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.
- Wanke, M. \& Szajewska, H. (2014). Probiotics for preventing healthcare-associated diarrhea inLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mayra Garcia, APRN, CNS principal investigator
Children's Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus rhamnosus GG (LGG) Probiotic in people with Appendicitis and Appendicitis; Perforation, run by Children's Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospital Stay (time frame: From admission to discharge, up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04529980, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.