Antisecretory Factor In Severe Traumatic Brain Injury

NCT04117672 | Recruiting Phase 2

• 1 other identifier: 2019-00553
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury; cerebral edema; antisecretory factor; inflammatory cytokines; cerebral oxygen monitoring; intracranial pressure; microdialysis

Outcome Measures

Primary Outcomes (1)

• ICP mean

  Measured by an intracranial pressure sensor

  During intervention, 5 days

Secondary Outcomes (1)

• Concentration of inflammatory cytokines

  During intervention, 5 days

Other Outcomes (14)

• Mortality

  At 30 days and 12 months

• Morbidity

  At 6 and 12 months

• Intracerebral oxygen partial pressure

  During intervention, 5 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Egg yolk powder not enriched for antisecretory powder

Dietary Supplement: Placebo egg yolk powder

Salovum

EXPERIMENTAL

Egg yolk powder enriched for antisecretory powder

Dietary Supplement: Salovum

Interventions

Salovum DIETARY_SUPPLEMENT

Active egg yolk powder

Also known as: Antisecretory factor

Salovum

Placebo egg yolk powder DIETARY_SUPPLEMENT

Normal egg yolk powder

Placebo

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known egg yolk allergy.
• Unilateral or bilateral fixed and dilated pupil after initial operative intervention.

Sponsors & Collaborators

• Peter Siesjö: lead
• Skane University Hospital: collaborator
• Lantmannen Medical AB: collaborator

Study Sites (1)

Skane University Hopsital

Lund, 22185, Sweden

RECRUITING

Related Publications (10)

• Ilkhanizadeh S, Sabelstrom H, Miroshnikova YA, Frantz A, Zhu W, Idilli A, Lakins JN, Schmidt C, Quigley DA, Fenster T, Yuan E, Trzeciak JR, Saxena S, Lindberg OR, Mouw JK, Burdick JA, Magnitsky S, Berger MS, Phillips JJ, Arosio D, Sun D, Weaver VM, Weiss WA, Persson AI. Antisecretory Factor-Mediated Inhibition of Cell Volume Dynamics Produces Antitumor Activity in Glioblastoma. Mol Cancer Res. 2018 May;16(5):777-790. doi: 10.1158/1541-7786.MCR-17-0413. Epub 2018 Feb 5.

  PMID: 29431617 BACKGROUND

• Clausen F, Hansson HA, Raud J, Marklund N. Intranasal Administration of the Antisecretory Peptide AF-16 Reduces Edema and Improves Cognitive Function Following Diffuse Traumatic Brain Injury in the Rat. Front Neurol. 2017 Feb 14;8:39. doi: 10.3389/fneur.2017.00039. eCollection 2017.

  PMID: 28261150 BACKGROUND

• Lonnroth I, Oshalim M, Lange S, Johansson E. Interaction of Proteasomes and Complement C3, Assay of Antisecretory Factor in Blood. J Immunoassay Immunochem. 2016;37(1):43-54. doi: 10.1080/15321819.2015.1042544.

  PMID: 25897558 BACKGROUND

• Al-Olama M, Lange S, Lonnroth I, Gatzinsky K, Jennische E. Uptake of the antisecretory factor peptide AF-16 in rat blood and cerebrospinal fluid and effects on elevated intracranial pressure. Acta Neurochir (Wien). 2015 Jan;157(1):129-37. doi: 10.1007/s00701-014-2221-7. Epub 2014 Sep 24.

  PMID: 25248325 BACKGROUND

• Johansson E, Al-Olama M, Hansson HA, Lange S, Jennische E. Diet-induced antisecretory factor prevents intracranial hypertension in a dosage-dependent manner. Br J Nutr. 2013 Jun 28;109(12):2247-52. doi: 10.1017/S0007114512004552. Epub 2012 Nov 16.

  PMID: 23153478 BACKGROUND

• Hansson HA, Al-Olama M, Jennische E, Gatzinsky K, Lange S. The peptide AF-16 and the AF protein counteract intracranial hypertension. Acta Neurochir Suppl. 2012;114:377-82. doi: 10.1007/978-3-7091-0956-4_73.

  PMID: 22327727 BACKGROUND

• Jennische E, Bergstrom T, Johansson M, Nystrom K, Tarkowski A, Hansson HA, Lange S. The peptide AF-16 abolishes sickness and death at experimental encephalitis by reducing increase of intracranial pressure. Brain Res. 2008 Aug 28;1227:189-97. doi: 10.1016/j.brainres.2008.05.083. Epub 2008 Jun 11.

  PMID: 18586012 BACKGROUND

• Lange S, Lonnroth I. The antisecretory factor: synthesis, anatomical and cellular distribution, and biological action in experimental and clinical studies. Int Rev Cytol. 2001;210:39-75. doi: 10.1016/s0074-7696(01)10003-3.

  PMID: 11580208 BACKGROUND

• Johansson E, Lonnroth I, Lange S, Jonson I, Jennische E, Lonnroth C. Molecular cloning and expression of a pituitary gland protein modulating intestinal fluid secretion. J Biol Chem. 1995 Sep 1;270(35):20615-20. doi: 10.1074/jbc.270.35.20615.

  PMID: 7657640 BACKGROUND

• Reen L, Cederberg D, Marklund N, Visse E, Siesjo P. Antisecretory factor in severe traumatic brain injury (AFISTBI): protocol for an exploratory randomized placebo-controlled trial. Trials. 2025 Feb 7;26(1):43. doi: 10.1186/s13063-025-08760-7.

  PMID: 39920739 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Edema

Interventions

antisecretory factor

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Peter Siesjö, MD, PhD

  Skane University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Siesjö, MD, PhD

CONTACT

+4646171274; peter.siesjo@med.lu.se

David Cederberg, MD

CONTACT

+4646177655; david.cederberg@med.lu.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Egg powder enriched for antisecretory factor and placebo egg powder with the same color, taste and texture,
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Participants with severe TBI and scheduled for multimodal monitoring will be randomised to active or placebo treatment.

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: October 7, 2019
• Study Start: March 10, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From 3 months after publication to 24 months after publication.
• Access Criteria: Anyone who wishes to access the data.

Locations

SE (1)