Infant botulism

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1FDA treatments30Specialists8Treatment centers

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Overview

Infant botulism (also known as infantile botulism) is a rare but serious neuroparalytic illness caused by the colonization of the infant intestinal tract by Clostridium botulinum (or rarely other botulinum toxin-producing Clostridium species), which produces botulinum neurotoxin in vivo. Unlike foodborne botulism in older individuals, infant botulism results from ingestion of bacterial spores rather than preformed toxin. The spores germinate and colonize the immature infant gut, where they produce toxin that is absorbed systemically. The toxin blocks acetylcholine release at the neuromuscular junction, leading to descending flaccid paralysis. The disease predominantly affects infants under 12 months of age, with peak incidence between 2 and 4 months. The hallmark presentation begins with constipation, followed by progressive weakness, poor feeding, weak cry, diminished suck and gag reflexes, decreased facial expression, ptosis, sluggish pupillary responses, and generalized hypotonia often described as a 'floppy baby.' In severe cases, respiratory failure may occur, requiring mechanical ventilation. Cranial nerve palsies are typically prominent. The severity ranges from mild illness with subtle hypotonia to fulminant paralysis. Sudden infant death syndrome (SIDS) has been associated with infant botulism in some cases. Treatment includes supportive care with careful attention to respiratory status, nutritional support, and monitoring in an intensive care setting. Botulism Immune Globulin Intravenous (BIG-IV, marketed as BabyBIG®) is the specific antitoxin approved for treatment of infant botulism caused by type A or type B toxin. Early administration of BIG-IV has been shown to significantly reduce hospital stay, duration of mechanical ventilation, and duration of tube feeding. Antibiotics are generally avoided as they may lyse bacteria in the gut and paradoxically increase toxin release. With appropriate supportive care and antitoxin therapy, the prognosis is generally excellent, with a case fatality rate of less than 1% in hospitalized infants. Recovery occurs as new neuromuscular junctions are formed, which may take weeks to months.

Also known as:

Clinical phenotype terms— hover any for plain English:

Abnormality of the pharynxHP:0000600Cardiac arrestHP:0001695
Inheritance

Sporadic

Usually appears on its own, not inherited from a parent

Age of Onset

Infantile

Begins in infancy, roughly 1 month to 2 years old

Orphanet ↗NORD ↗

FDA & Trial Timeline

2 events
Mar 2026GAMIFANT: New indication approved
FDAcompleted
Oct 2003

BabyBIG: FDA approved

Indicated for treatment of infant botulism caused by type A or type B Clostridium botulinum.

FDAcompleted

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Treatments

1 available

BabyBIG

Botulism immune globulin· California Department of Public HealthOrphan Drug

Indicated for treatment of infant botulism caused by type A or type B Clostridium botulinum.

No actively recruiting trials found for Infant botulism at this time.

New trials open frequently. Follow this disease to get notified.

Search ClinicalTrials.gov ↗Join the Infant botulism community →

Specialists

Showing 25 of 30View all specialists →
GS
Gowri Stevens
HOUSTON, TX
Specialist
1 Infant botulism publication
AG
Ashley Garispe
COLTON, CA
Specialist
1 Infant botulism publication
JW
Jessica Wilson
Specialist
1 Infant botulism publication
RW
Robert Wians
HOUSTON, TX
Specialist
1 Infant botulism publication
VM
Victoria Morris
Specialist
1 Infant botulism publication
SC
Steven Cherry
Specialist
1 Infant botulism publication
BG
Bar Goldberg
Specialist
1 Infant botulism publication
HD
Haydee A Dabritz
Specialist
3 Infant botulism publications
JK
Jessica M Khouri
Specialist
3 Infant botulism publications
JB
Jason R Barash
Specialist
2 Infant botulism publications
ND
Nir Dover
Specialist
2 Infant botulism publications
RH
Richard A Harris
Specialist
1 Infant botulism publication
CC
Connie H Chung
Specialist
2 Infant botulism publications
JR
Jennifer S Read
Specialist
2 Infant botulism publications
MP
Mayuri V Panditrao
Specialist
2 Infant botulism publications
KL
K C Li
Specialist
2 Infant botulism publications
SQ
S Y Qian
Specialist
2 Infant botulism publications
XJ
X L Jia
Specialist
2 Infant botulism publications
CF
C N Fan
Specialist
2 Infant botulism publications
QW
Q Wang
Specialist
2 Infant botulism publications
MD
Martin B Dorner
Specialist
2 Infant botulism publications
HS
Harri Saxén
Specialist
2 Infant botulism publications
YD
Yağmur Derman
Specialist
2 Infant botulism publications
FD
François P Douillard
Specialist
2 Infant botulism publications
GC
Gema Carrasco
SAN DIEGO, CA
Specialist
2 Infant botulism publications

Treatment Centers

8 centers
🏥 NORD

Baylor College of Medicine Rare Disease Center

Baylor College of Medicine

📍 Houston, TX

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

🔬 UDN

UCLA UDN Clinical Site

UCLA Health

📍 Los Angeles, CA

🔬 UDN

Baylor College of Medicine UDN Clinical Site

Baylor College of Medicine

📍 Houston, TX

🔬 UDN

Harvard/MGH UDN Clinical Site

Massachusetts General Hospital

📍 Boston, MA

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🏥 NORD

UCLA Rare Disease Day Program

UCLA Health

📍 Los Angeles, CA

Travel Grants

No travel grants are currently matched to Infant botulism.

Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Infant botulism

1 articles
NewsFDA
FDA Approves GAMIFANT
GAMIFANT (EMAPALUMAB-LZSG) received FDA approval.
See all news about Infant botulism

Caregiver Resources

NORD Caregiver Resources

Support, advocacy, and financial assistance for caregivers of rare disease patients.

Mental Health Support

Rare disease caregiving can be isolating. Connect with counseling and peer support.

Family & Caregiver Grants

Financial assistance programs specifically for caregivers of rare disease patients.

Social Security Disability

Learn how rare disease patients may qualify for SSDI/SSI benefits.

Common questions about Infant botulism

What is Infant botulism?

Infant botulism (also known as infantile botulism) is a rare but serious neuroparalytic illness caused by the colonization of the infant intestinal tract by Clostridium botulinum (or rarely other botulinum toxin-producing Clostridium species), which produces botulinum neurotoxin in vivo. Unlike foodborne botulism in older individuals, infant botulism results from ingestion of bacterial spores rather than preformed toxin. The spores germinate and colonize the immature infant gut, where they produce toxin that is absorbed systemically. The toxin blocks acetylcholine release at the neuromuscular

How is Infant botulism inherited?

Infant botulism follows a sporadic inheritance pattern. Genetic counseling can help families understand recurrence risk and testing options.

At what age does Infant botulism typically begin?

Typical onset of Infant botulism is infantile. Age of onset can vary across affected individuals.

Which specialists treat Infant botulism?

25 specialists and care centers treating Infant botulism are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.

What treatment and support options exist for Infant botulism?

1 patient support program are currently tracked on UniteRare for Infant botulism. See the treatments and support programs sections for copay assistance, eligibility, and contact details.