A Phase 2 interventional study of Salovum and Placebo egg yolk powder in Traumatic Brain Injury, sponsored by Peter Siesjö. Recruiting at 1 site in Sweden. Open to participants aged 10 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Peter Siesjö · Phase 2, Interventional, and Treatment
This study evaluates the addition of Salovum, an egg yolk powder enriched for antisecretory factor, to standard care of participants with severe traumatic brain injury. Half of the participants will be administered Salovum while the other half will be given a placebo egg yolk powder, not enriched for antisecretory factor. Intracranial pressure (ICP), partial brain oxygen pressure (PtbO2), microdialysis of metabolites and inflammatory mediators and trauma intensity level (TIL) will be assessed in all patients.
Cerebral edema accounts for an essential part of the morbidity and mortality in severe traumatic brain injury but can also arise in other cerebral pathologies such as infectious and ischemic conditions such e.g. stroke and meningitis. Cerebral edema can lead to an elevated intracranial pressure (ICP) with impact on both perfusion and diffusion in the brain.
AF (antisecretory factor) is a 41 kilodalton endogenous and essential protein with proposed antisecretory and anti-inflammatory effects. AF is homologous to S5A and Rpn10 proteins which are parts of the 26S proteasome subunit. AF also shows close homology to angiocidin a protein with reported anti-proliferative and anti-angiogenic properties. The AF protein is cleaved into several active peptides, one of which has been synthesized within a 16 amino acid peptide (AF-16) that has been used in animal experimental studies. Salovum® is a product based on the egg yolk powder B221®, and contains high levels of AF. Salovum® is classified as a food for special medical purposes (FSMP) by the European Food Safety Agency.
AF has shown clinical effects in Mb Ménière, mastitis and meningitis. Experimentally AF-16 and AF have been shown to reduce intracranial pressure and improve outcome in models of traumatic brain injury (TBI) and herpes encephalitis. Preliminary results show reduction of ICP and improved outcome in human traumatic brain injury. A randomized, prospective, double-blinded phase 2-3 in participants with severe traumatic head injury is ongoing at Tygerberg University Hospital, Cape Town, South Africa (ClinicalTrials.gov identification number: NCT03339505).
The antisecretory factor is an endogenous protein and no antibody formation has been demonstrated in human administration. Although Salovum® has been given to hundreds of patients, no side effects have been recorded. Egg yolk allergy is a contraindication but no cases of triggered allergy have been reported.
The mechanisms underlying the effects of antisecretory factor on cerebral edema are not clarified. Immune modulation through effects on myeloid cells, proteasome modulation and effects on ion pumps have been proposed.
The present study intends to clarify mechanisms behind the proposed effect of antisecretory factor in cerebral edema In the present study participants with severe traumatic brain injury as defined in inclusion and exclusion criteria will be randomised to either treatment with Salovum or placebo egg powder during 5 days after enrolment. Randomisation will be performed in blocks and randomisation envelopes will be used with the number inside the envelope. Salovum and normal egg powder will be suspended with tap water and administered through the gastric feeding tube. All participants will receive standard care for severe TBI according to the treatment algorithm at the Neuro Intensive Care Unit (NICU), Department of Neurosurgery, Skåne University Hospital, Lund, Sweden. The algorithm prescribes invasive monitoring of ICP, PtbO2 and metabolites (cerebral microdialysis). As this algorithm includes stepwise co-interventions in order to control ICP and cerebral perfusion pressure (CPP) the TIL score will be used to compensate for the bias of increased co-interventions in either arm. At follow up patients will be assessed for mortality and Glasgow Outcome Scale-Extended (GOSE)
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 20 is below the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Peter Siesjö is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
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Severe traumatic brain injury, Glasgow Outcome Scale (GCS) \<9 at admission to NICU.
Clinical indication for insertion of intracranial pressure monitor, intracerebral oxygen pressure monitor and microdialysis catheter.
Consultation with relatives or consent from guardians.
Exclusion Criteria:
Known egg yolk allergy.
Unilateral or bilateral fixed and dilated pupil after initial operative intervention.
Egg yolk powder not enriched for antisecretory powder
Dietary Supplement: Placebo egg yolk powder
Egg yolk powder enriched for antisecretory powder
Dietary Supplement: Salovum
Active egg yolk powder
Also known as: Antisecretory factor
Normal egg yolk powder
ICP mean
Measured by an intracranial pressure sensor
Time frame: During intervention, 5 days
Concentration of inflammatory cytokines
Interleukin-6 (Il-6), interleukin-8 (IL-8) and monocyte chemotactic protein (MCP-1) assessed from microdialysate and plasma by multiplex analysis
Time frame: During intervention, 5 days
Mortality
Mortality due to traumatic brain injury
Time frame: At 30 days and 12 months
Morbidity
Assessed by Glagow Outcome Scale-Extended (GOSE). Minimum 1 (full recovery). MAXIMUM 8 (DEAD)
Time frame: At 6 and 12 months
Intracerebral oxygen partial pressure
Measured by an intracranial oxygen sensor
Time frame: During intervention, 5 days
Intracerebral oxygen partial pressure
Lactate/pyruvate ratio assessed by online microdialysis
Time frame: Change from baseline during intervention, up to 6 days
Treatment intensity level
Treatment intensity level (TIL) scale. Minimum 0 (no intervention to control intracranial pressure (ICP)), maximum 38 points (maximum efforts to control ICP)
Time frame: During intervention, 5 days
Treatment intensity level
Treatment intensity level (TIL) scale. Minimum 0 (no intervention to control intracranial pressure (ICP)), maximum 38 points (maximum efforts to control ICP)
Time frame: Change from baseline during intervention, up to 6 days
Rate of cerebral metabolism
Lactate/pyruvate ratio assessed by online microdialysis
Time frame: During intervention, 5 days
Rate of cerebral metabolism
Lactate/pyruvate ratio assessed by online microdialysis
Time frame: Change from baseline during intervention, up to 6 days
Concentration of brain damage markers
Glial fibrillary acidic protein (GFAP) and neuron-specific enolase (NSE) assessed from microdialysate and plasma
Time frame: During intervention, 5 days
Concentration of brain damage markers
Glial fibrillary acidic protein (GFAP) and neuron-specific enolase (NSE) assessed from microdialysate and plasma
Time frame: Change from baseline during intervention, up to 6 days
ICP area under curve
Measured by an intracranial pressure sensor
Time frame: During intervention, 5 days
ICP area under curve
Measured by an intracranial pressure sensor
Time frame: Change from baseline during intervention, up to 6 days
ICP mean
Measured by an intracranial pressure sensor
Time frame: Change from baseline during intervention, up to 6 days
Concentration of inflammatory cytokines
Interleukin-6 (Il-6), interleukin-8 (IL-8) and monocyte chemotactic protein (MCP-1) assessed from microdialysate and plasma by multiplex analysis
Time frame: Change from baseline during intervention, up to 6 days
Plan to share: Yes — Individual patient data that underlie published results will be made available after publication.after de identification.
Supporting information: Study protocol
Time frame: From 3 months after publication to 24 months after publication.
Access criteria: Anyone who wishes to access the data.
Started Mar 2020 (actual). Primary completion is estimated for Dec 2026, 81 months after the start.
Of 46 phase 2 interventional studies under Brain Injuries, Traumatic, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 30. This study's planned 81 months is above that.
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Studies of the drug tested here: Antisecretory Factor-enriched Egg Yolk Powder Supplement
Peter Siesjö