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Not yet recruitingNCT05997745PAG/NUTRIUpdated Aug 18, 2023

Enteral Nutrition in Acute Generalized Peritonitis

An interventional study of study group in Enteral and Supplement Feeds Adverse Reaction and Peritonitis; Acute, sponsored by Université Evangélique enAfrique. Not yet recruiting. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2023-08-18.

Sponsored by Université Evangélique enAfrique · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
2 Years and older
Sex
All
01

Study summary

Hospitals in South Kivu always have problems supplying artificial enteral nutritional products because of their high cost and low availability in our areas. While the Province has cereals, knowing their nutritional composition would enable the formulation of a nutritional product based on local protein-energy products. Hence the questions below: Can a local cereal-based protein-energy ration be used instead of a costly imported artificial nutritional solution to improve the nutritional status of patients operated on for PAG? What is the tolerance of this early enteral nutrition on the healing and functional recovery of patients compared with an artificial nutritional solution? To answer these questions, a randomized clinical trial has been designed with the following objectives:

  • To formulate an enteral diet using cereals available in our environment with a protein-calorie composition superimposable on the artificial enteral ration,
  • Evaluate the tolerance and advantages of early enteral nutrition with a locally manufactured protein-caloric ration vs. a commercially available artificial nutritional solution in patients undergoing surgery for PAG.
02

Conditions studied

  • Enteral and Supplement Feeds Adverse Reaction
  • Peritonitis; Acute

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03

In context

Peritonitis

167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.

This study's planned enrollment of 76 is close to the median of 79 across 106 interventional studies indexed under Peritonitis.

Browse Peritonitis studies →

Lead sponsor

Université Evangélique enAfrique is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patient operated for peritonitis with intestinal suture during treatment
  • have a q-SOFA score of 1 to 2
  • surgeon's agreement to enteral feeding
  • at risk of malnutrition (BMC)

Exclusion criteria

Exclusion Criteria:

  • q SOFA score > 2
  • patients with tare (diabetes, , renal failure)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    study group

    an intervention arm consisting of patients who will receive the locally manufactured protein-energy ration after a laparotomy indicated for generalized acute peritonitis

    Dietary Supplement: study group

  • Active comparator
    control group

    patients who will receive the commercially available protein-energy ration after a laparotomy indicated for generalized acute peritonitis

    Dietary Supplement: study group

Interventions

  • Dietary supplementstudy group

    Patients will receive early enteral locally nutrition postoperatively following surgery for peritonitis

06

What researchers measure

Primary outcomes

  1. Tolerability of feeding

    We will screen complications after feeding

    Time frame: 10 days after surgery

Secondary outcomes

  1. nutritional surveillance

    changes in nutritional status using body mass index, albumin measurement, anthropometric data

    Time frame: 2 days after, 5 days after, 10 days after feeding

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2023; primary completion for Oct 2023, 2 months later.

Of 23 interventional studies with no phase under Peritonitis, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 2 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 7, 2023
First posted
Aug 18, 2023
StartEst.
Aug 20, 2023
Primary completionEst.
Oct 30, 2023
CompletionEst.
Oct 30, 2023
Last update
Aug 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05997745
Lead sponsor
Université Evangélique enAfrique
Responsible party
Sponsor
First posted
Aug 18, 2023
Start date
Aug 20, 2023 (estimated)
Primary completion
Oct 30, 2023 (estimated)
Completion
Oct 30, 2023 (estimated)
Last update
Aug 18, 2023

Study contacts

JEAN PAUL CIKWANINE, MASTER
Contact
jpcikwa1@gmail.com
+243990860491

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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