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Enteral Feeding IntolerancePhase 2/3AmoxENINCT05828758

Amoxicillin for Enteral Nutrition Intolerance in Pediatric Intensive Care Unit

A Phase 2/3 study testing Amoxicillin in people with Enteral Feeding Intolerance, run by Sohag University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this randomized controlled study is to investigate the efficacy of enteral amoxicillin for the treatment of children with feeding intolerance in pediatric intensive care unit. Children with feeding intolerance will be randomized into study and comparison groups. Read more about this study

Who is it for?
Ages 1 month to 12 years
Conditions the study is for
Enteral Feeding Intolerance
What is being tested?
Amoxicillin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteEgypt
Study dates
24 Apr 2023to 10 May 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

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 1 month to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age ranges from 1 month to 12 years.
  • Nasogastric tube feeding
  • Enteral nutrition intolerance after 7 days of admission to the PICU.

Who cannot join

  • Failure to obtain informed consent.
  • Allergy or contraindication to amoxicillin or other beta-lactam antibiotics.
  • Current or recent (within 7 days) treatment with amoxicillin.
  • Ongoing ketogenic diet.
  • Clinical contraindications to advance EN feeds (e.g., bowel obstruction/tight stenosis, severe diarrhea/malabsorption, gut ischemia, severe hypoxemia/acidosis, intractable upper gastrointestinal bleeding, abdominal compartment syndrome, high-output fistula).

Trial locations and contacts

1 site in 1 country.

Abanob Francis, MBBCh contact

0201094930123

abanobamgad@med.sohag.edu.eg

Elsayed Abdelkreem, MD, PhD contact

+201114232126

d.elsayedmohammed@med.sohag.edu.eg

Egypt1 site, 1 recruiting

  • Pediatric Intensive Care Unit - Sohag University Hospital

    Sohag, 82524

    Abdelrahim A Sadek, MD, PhD, +201065067057, abdoneurology@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Official title: Efficacy of Amoxicillin for Treatment of Enteral Nutrition Intolerance in Pediatric Intensive Care Unit

The goal of this randomized controlled study is to investigate the efficacy of enteral amoxicillin for the treatment of children with feeding intolerance in pediatric intensive care unit.

Children with feeding intolerance will be randomized into study and comparison groups. The study group will receive amoxicillin 10 mg/kg by nasogastric tube 3 times daily 10 minutes before bolus gastric feeding for 7 days. The comparison group will receive equal volume of distilled water as a placebo.

The primary outcome will be the improvement of feeding intolerance on day 7 study timepoint.

Read the detailed description

Malnutrition is a common problem in critically ill children admitted to the pediatric intensive care unit (PICU) with a reported prevalence up to 57%. This condition is associated with increased length of hospital stay, morbidity (e.g., hospital-acquired infections, weakness, and longer duration of mechanical ventilation), and mortality. Data from observational studies indicate that adequate energy intake is associated with better outcomes in the PICU.

Enteral nutrition (EN) is the preferred route to administer nutritional support for critically ill children unless contraindicated. However, EN of critically ill children is challenging, and nutritional targets are commonly not attained.

EN intolerance (a clinical manifestation of delayed gastric emptying) is one of the main factors for limited delivery of enteral feeding. Promotility agents are commonly used as a first-line treatment for patients with EN intolerance. In critically ill adults, prokinetics have been shown to improve gastric emptying and enhance tolerance to gastric feeding. Available options include metoclopramide, domperidone, and erythromycin. However, there is insufficient evidence for recommending the use of prokinetics in children with critical illness to enhance gastric emptying and EN tolerance. Furthermore, currently available prokinetics are associated with serious side effects.

Amoxicillin/clavulanate combination is one of the most commonly prescribed antibiotics for children worldwide. Besides its antibacterial properties, some studies showed that amoxicillin/clavulanate could have prokinetic effects. However, well-designed randomized controlled trials to confirm the prokinetic effects of amoxicillin/clavulanate are lacking. Additionally, no human study has investigated the prokinetic effects of amoxicillin and clavulanate individually. In a study on juvenile rats, amoxicillin alone, but not clavulanate, was shown to increase the amplitude of spontaneous duodenal contractions. The use of amoxicillin alone rather than amoxicillin/clavulanate could have the advantages of avoiding the side effects of clavulanate, lowering the cost, and decreasing the risk of antibiotic resistance.

The goal of this randomized controlled study is to investigate the efficacy of enteral amoxicillin for the treatment of children with EN intolerance in PICU.

Being tested
Amoxicillin, Placebo
Keywords
Feeding intolerance, Pediatric intensive care unit, PICU, Amoxicillin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmoxicillinDrug

    Amoxicillin 10 mg/kg (50 mg/ml concentration) by nasogastric tube 3 times daily (8 hours apart) 10 minutes before bolus gastric feeding for 7 days.

  • PlaceboOther

    Distilled water 0.2 ml/kg by nasogastric tube 3 times daily (8 hours apart) 10 minutes before bolus gastric feeding for 7 days.

Study groups in NCT05828758
Study groupRoleWhat they receive
Study groupExperimentalChildren receiving amoxicillin
Receives: Drug: Amoxicillin
Comparison groupPlacebo comparatorChildren receiving placebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feeding tolerance on day 7

    Proportion of participants achieving feeding tolerance (enteral intake ≥ two-thirds of the prescribed daily target in the absence of gastrointestinal symptoms, including large gastric residual volume (≥ 50% of enteral feeding in the last 4 hours), vomiting (≥ 2 times gastric content in 24 hours period), diarrhea (≥ 4 times loose stool with negative fluid balance in 24 hours period), abdominal distention (≥ 2 cm increase in abdominal girth), abdominal pain, melena, or hematochezia) on day 7 study timepoint

    Measured: 7 days

Secondary outcomes (8)

  1. Enteral intake ≥ two-thirds of the prescribed daily target on day 7

    Proportion of participants achieving enteral intake ≥ two-thirds of the prescribed daily target on day 7 study timepoint

    Measured: 7 days

  2. Change in achieved percentage of prescribed enteral feeding on day 7 study compared with baseline

    Change in achieved percentage of prescribed enteral feeding on day 7 study timepoint compared with baseline

    Measured: 7 days

  3. Large gastric residual volume on day 7

    Proportion of participants with large gastric residual volume (≥ 50% of enteral feeding in the last 4 hours) on day 7 study timepoint

    Measured: 7 days

  4. Vomiting on day 7

    Proportion of participants with vomiting (≥ 2 times gastric content in 24 hours period) on day 7 study timepoint

    Measured: 7 days

  5. Diarrhea

    Proportion of participants with diarrhea (≥ 4 times loose stool with negative fluid balance in 24 hours period)

    Measured: 7 days

  6. Abdominal distention

    Proportion of participants with abdominal distention (≥ 2 cm increase in abdominal girth)

    Measured: 7 days

  7. Melena/hematochezia

    Proportion of participants with melena/hematochezia

    Measured: 7 days

  8. Skin rash

    Proportion of participants with skin rash

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2023
  2. Study start24 Apr 2023
  3. Primary completion1 May 2024 (estimated)
  4. Study completion10 May 2024 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two groups of children with enteral feeding intolerance: Study group: will receive amoxicillin 10 mg/kg (50 mg/ml concentration) by nasogastric tube 3 times daily (8 hours apart) 10 minutes before bolus gastric feeding for 7 days. The nasogastric tube will be flushed by 5 ml distilled water after each dose. Control group: will receive equal volume of distilled water (0.2 ml/kg + 5 ml) as a placebo.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05828758
Sponsor's protocol ID
Soh-Med-23-04-16MS
Acronym
AmoxENI
Status last verified
Apr 2023
First submitted
12 Apr 2023
Last updated
26 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Unidentified individual participant data will be available after publication from the principal investigator upon a reasonable request

Publications

  • Martinez EE, Douglas K, Nurko S, Mehta NM. Gastric Dysmotility in Critically Ill Children: Pathophysiology, Diagnosis, and Management. Pediatr Crit Care Med. 2015 Nov;16(9):828-36. doi: 10.1097/PCC.0000000000000493.

    PubMed 26218259

  • Eveleens RD, Hulst JM, de Koning BAE, van Brakel J, Rizopoulos D, Garcia Guerra G, Vanhorebeek I, Van den Berghe G, Joosten KFM, Verbruggen SCAT. Achieving enteral nutrition during the acute phase in critically ill children: Associations with patient characteristics and clinical outcome. Clin Nutr. 2021 Apr;40(4):1911-1919. doi: 10.1016/j.clnu.2020.09.005. Epub 2020 Sep 16.

    PubMed 32981755

  • Tume LN, Valla FV, Joosten K, Jotterand Chaparro C, Latten L, Marino LV, Macleod I, Moullet C, Pathan N, Rooze S, van Rosmalen J, Verbruggen SCAT. Nutritional support for children during critical illness: European Society of Pediatric and Neonatal Intensive Care (ESPNIC) metabolism, endocrine and nutrition section position statement and clinical recommendations. Intensive Care Med. 2020 Mar;46(3):411-425. doi: 10.1007/s00134-019-05922-5. Epub 2020 Feb 20.

    PubMed 32077997

  • Mehta NM, Skillman HE, Irving SY, Coss-Bu JA, Vermilyea S, Farrington EA, McKeever L, Hall AM, Goday PS, Braunschweig C. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Pediatric Critically Ill Patient: Society of Critical Care Medicine and American Society for Parenteral and Enteral Nutrition. Pediatr Crit Care Med. 2017 Jul;18(7):675-715. doi: 10.1097/PCC.0000000000001134.

    PubMed 28691958

  • Kratochvil M, Klucka J, Klabusayova E, Musilova T, Vafek V, Skrisovska T, Djakow J, Havrankova P, Osinova D, Stourac P. Nutrition in Pediatric Intensive Care: A Narrative Review. Children (Basel). 2022 Jul 11;9(7):1031. doi: 10.3390/children9071031.

    PubMed 35884015

  • Martinez EE, Pereira LM, Gura K, Stenquist N, Ariagno K, Nurko S, Mehta NM. Gastric Emptying in Critically Ill Children. JPEN J Parenter Enteral Nutr. 2017 Sep;41(7):1100-1109. doi: 10.1177/0148607116686330. Epub 2017 Jan 6.

    PubMed 28061320

  • Eveleens RD, Joosten KFM, de Koning BAE, Hulst JM, Verbruggen SCAT. Definitions, predictors and outcomes of feeding intolerance in critically ill children: A systematic review. Clin Nutr. 2020 Mar;39(3):685-693. doi: 10.1016/j.clnu.2019.03.026. Epub 2019 Mar 30.

    PubMed 30962102

  • Peng R, Li H, Yang L, Zeng L, Yi Q, Xu P, Pan X, Zhang L. The efficacy and safety of prokinetics in critically ill adults receiving gastric feeding tubes: A systematic review and meta-analysis. PLoS One. 2021 Jan 11;16(1):e0245317. doi: 10.1371/journal.pone.0245317. eCollection 2021.

    PubMed 33428672

  • Chiusolo F, Capriati T, Erba I, Bianchi R, Ciofi Degli Atti ML, Picardo S, Diamanti A. Management of Enteral Nutrition in the Pediatric Intensive Care Unit: Prokinetic Effects of Amoxicillin/Clavulanate in Real Life Conditions. Pediatr Gastroenterol Hepatol Nutr. 2020 Nov;23(6):521-530. doi: 10.5223/pghn.2020.23.6.521. Epub 2020 Nov 5.

    PubMed 33215023

  • Gomez R, Fernandez S, Aspirot A, Punati J, Skaggs B, Mousa H, Di Lorenzo C. Effect of amoxicillin/clavulanate on gastrointestinal motility in children. J Pediatr Gastroenterol Nutr. 2012 Jun;54(6):780-4. doi: 10.1097/MPG.0b013e31824204e4.

    PubMed 22584747

  • Caron F, Ducrotte P, Lerebours E, Colin R, Humbert G, Denis P. Effects of amoxicillin-clavulanate combination on the motility of the small intestine in human beings. Antimicrob Agents Chemother. 1991 Jun;35(6):1085-8. doi: 10.1128/AAC.35.6.1085.

    PubMed 1929247

  • Ciciora SL, Williams KC, Gariepy CE. Effects of Amoxicillin and Clavulanic Acid on the Spontaneous Mechanical Activity of Juvenile Rat Duodenum. J Pediatr Gastroenterol Nutr. 2015 Sep;61(3):340-5. doi: 10.1097/MPG.0000000000000804.

    PubMed 25844706

  • Hulst JM, Zwart H, Hop WC, Joosten KF. Dutch national survey to test the STRONGkids nutritional risk screening tool in hospitalized children. Clin Nutr. 2010 Feb;29(1):106-11. doi: 10.1016/j.clnu.2009.07.006. Epub 2009 Aug 13.

    PubMed 19682776

  • Straney L, Clements A, Parslow RC, Pearson G, Shann F, Alexander J, Slater A; ANZICS Paediatric Study Group and the Paediatric Intensive Care Audit Network. Paediatric index of mortality 3: an updated model for predicting mortality in pediatric intensive care*. Pediatr Crit Care Med. 2013 Sep;14(7):673-81. doi: 10.1097/PCC.0b013e31829760cf.

    PubMed 23863821

  • Abdelatif RG, Francis AA, Abdelkreem E, Ahmed SH. Amoxicillin for critically ill children with enteral nutrition intolerance (AmoxENI study): A randomized controlled trial. J Pediatr Gastroenterol Nutr. 2025 Sep;81(3):712-721. doi: 10.1002/jpn3.70105. Epub 2025 Jun 12.

    PubMed 40501446

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Amoxicillin in people with Enteral Feeding Intolerance, run by Sohag University at 1 site in Egypt.

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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Apr 2023. 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 Egypt. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Abanob Francis, MBBCh (0201094930123, abanobamgad@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feeding tolerance on day 7 (time frame: 7 days). 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 NCT05828758, which also lists 15 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 26 Apr 2023.

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